The CardioSEAL Septal Occlusion System

Instructions For Use - VSD

Table of Contents

[1. PRODUCT DESCRIPTION 1](#product-description)

[2. INDICATION FOR USE 1](#indication-for-use)

[3. CONTRAINDICATIONS 1](#contraindications)

[4. WARNINGS 1](#warnings)

[5. PRECAUTIONS 2](#precautions)

[5.1 CardioSEAL -- Handling Precautions
2](#cardioseal-handling-precautions)

[5.2 CardioSEAL -- Sizing Precautions 2](#cardioseal-sizing-precautions)

[5.3 CardioSEAL -- Procedural Precautions
2](#cardioseal-procedural-precautions)

[5.4 CardioSEAL -- Post Implant Precautions
3](#cardioseal-post-implant-precautions)

[6. ADVERSE EVENTS Error! Bookmark not
defined.](#__RefHeading___Toc516999477)

[6.1 Observed Adverse Events Error! Bookmark not
defined.](#__RefHeading___Toc516999478)

[Device Related Error! Bookmark not
defined.](#__RefHeading___Toc516999479)

[Upper respiratory tract infection Error! Bookmark not
defined.](#__RefHeading___Toc516999480)

[Urinary retention Error! Bookmark not
defined.](#__RefHeading___Toc516999481)

[Venous thrombosis, suspected Error! Bookmark not
defined.](#__RefHeading___Toc516999482)

[Ventricular tachycardia Error! Bookmark not
defined.](#__RefHeading___Toc516999483)

[Wheezing Error! Bookmark not defined.](#__RefHeading___Toc516999484)

[Number of Events Error! Bookmark not
defined.](#__RefHeading___Toc516999485)

[Total Error! Bookmark not defined.](#__RefHeading___Toc516999486)

[TOTAL Error! Bookmark not defined.](#__RefHeading___Toc516999487)

[6.2 Potential Adverse Events 4](#potential-adverse-events)

[6.3 Observed Device Malfunctions 4](#observed-device-malfunctions)

[7. CLINICAL STUDIES 4](#clinical-studies)

[7.1 Study Design/Objective 4](#study-designobjective)

[7.2 Patient Entry 5](#patient-entry)

[7.3 Methods 5](#methods)

[7.4 Primary Endpoints 5](#primary-endpoints)

[7.5 Results 6](#results)

[8. HOW SUPPLIED 8](#how-supplied)

[9. DIRECTIONS FOR USE 8](#directions-for-use)

[9.1 Detailed Product Description 8](#detailed-product-description)

[9.2 CardioSEAL Size Selection and Inspection
8](#cardioseal-size-selection-and-inspection)

[9.3 Preparation for Delivery 9](#preparation-for-delivery)

[9.4 General Description of the CardioSEAL Occluder and Front Loading
Delivery System with Qwik load adaptation
9](#general-description-of-the-cardioseal-occluder-and-front-loading-delivery-system-with-qwik-load-adaptation)

[9.5 Attachment and Loading of the Occluder to the FL Delivery System
11](#attachment-and-loading-of-the-occluder-to-the-fl-delivery-system)

[9.6 Insertion 15](#insertion)

[10. PATIENT INFORMATION 19](#patient-information)

**CardioSEAL Septal Occlusion System with QwikLoad**

**Instructions for Use**

Caution : Federal law (USA) restricts this device to sale by or on the
order of a physician.

# PRODUCT DESCRIPTION

The CardioSEAL Septal Occlusion System consists of two primary
components:

-   The CardioSEAL (Occluder), a permanent implant, which is constructed
    of a metal (MP35N) framework to which polyester fabric is attached,
    and

-   The Delivery Catheter, a coaxial polyurethane catheter designed
    specifically to facilitate attachment, loading, delivery and
    deployment of the CardioSEAL to the defect.

The occluder is available in sizes 17mm, 23mm, 28mm and 33mm.

# INDICATION FOR USE

The CardioSEAL Septal Occlusion System is for use in patients with a
complex ventricular septal defect (VSD) of a significant size to warrant
closure, but that based on location, cannot be closed with standard
transatrial or transarterial approaches.

# CONTRAINDICATIONS

Presence of thrombus at the intended site of implant, or documented
evidence of venous thrombus in the vessels through which access to the
defect is gained.

Active endocarditis, or other infections producing a bacteremia.

Patients whose vasculature, through which access to the defect is
gained, is inadequate to accommodate the appropriate size sheath.

Patients whose defect is too small to allow the 10 F sheath to cross the
defect.

Anatomy in which the CardioSEAL size required would interfere with other
intracardiac or intravascular structures, such as valves or pulmonary
veins.

Patients with coagulation disorders who are unable to take Aspirin,
Heparin, Coumadin, or other anticoagulants.

# WARNINGS

This device should only be used by those physicians trained in
transcatheter defect closure techniques.

Physicians attempting to recover an embolized device should be limited
to those that have completed appropriate device retrieval technique
training.

Embolized CardioSEAL devices should be removed. Dislodged CardioSEALs
have embolized to the pulmonary and systemic vasculature.

Embolized CardioSEALs may disrupt critical cardiac functions. Physicians
must be prepared to deal with urgent requirements to extract or move
embolized CardioSEALs that result in critical hemodynamic compromise.

Embolized CardioSEALs should not be withdrawn through intracardiac
structures unless they have been adequately collapsed within a sheath.
Devices that are not adequately collapsed within a sheath may entangle
valvular or other cardiac structures.

Do not attempt to repair or reuse damaged product. Do not reuse or
resterilize product. Return to manufacturer.

Surgical support should be readily available if needed.

Transient hemodynamic compromise may be encountered during device
placement, which may require fluid replacement or other medications as
determined by the physician.

# PRECAUTIONS

## CardioSEAL -- Handling Precautions

Do not use the system if, during loading of the CardioSEAL, difficulty
is encountered in transferring the CardioSEAL into the loader or from
the loader.

Do not modify the delivery catheter or CardioSEAL. Modification may
result in damage that can result in complications such as embolism,
framework fracture, failure to release, and improper seating at the
target defect.

## CardioSEAL -- Sizing Precautions 

The use of a compliant balloon catheter to determine defect localization
is recommended.

Accurate defect sizing is critical to CardioSEAL size selection. Defect
sizing methods, such as contrast angiography, echocardiography and / or
balloon sizing should be considered as procedural alternatives. The
defect and surrounding structures should be fully examined in multiple
planes to assure proper sizing of the CardioSEAL.

The anatomic area surrounding the target defect should have sufficient
contiguous structure to support the CardioSEAL.

## CardioSEAL -- Procedural Precautions

The ability of the patient to remain still during implantation must be
weighed against the need for "conscious" sedation versus general
anesthesia. The decision to use general anesthesia in any individual
patient is subject to physician judgment.

Patients should be fully heparinized throughout the procedure using
adequate dosing so as to keep the ACT greater than 200 msec.

Antibiotic therapy periprocedurally is recommended to reduce the risk of
perioperative infection.

The use of Transesophageal Echocardiography (TEE) should be considered
as a potential aid in placing the CardioSEAL.

Placement of the CardioSEAL requires the use of fluoroscopic X-ray
guidance. The risk of increased x-ray exposure for patients who are
pregnant must be weighed against the potential benefits of the
technique.

Malpositioned CardioSEALs may interfere with cardiac, vascular or
valvular structures. Physicians should consider removing malpositioned
CardioSEALs in these patients.

## CardioSEAL -- Post Implant Precautions

The time course of endothelialization of the device is unknown. Patients
should receive appropriate endocarditis prophylaxis for the six months
following implantation. The decision to continue prophylactic treatment
after six months is subject to physician judgment.

Patients should be treated with antiplatelet/anticoagulation therapy,
such as Aspirin (see Section 8 Clinical Studies for the dosage used in
the High-Risk Study) for six-months following implant. The decision to
continue medical treatment beyond six months is subject to physician
judgment.

All CardioSEALs are non-ferromagnetic. Independent studies of the
CardioSEAL in a 1.5 Tesla magnetic field demonstrated no movement of the
CardioSEAL. However, MRI image quality may be compromised in the area of
the implant.

**6.0 Adverse Events**

1.  Observed Adverse Events

Observed adverse events are summarized in Table 1.

# Table 1 - Observed Adverse Events {#table-1---observed-adverse-events .unnumbered}

+-----------------------+----------------------+-----------------------+
|                       | ### **Percent** {#   | ### **Number**        |
|                       | percent .unnumbered} | {#number .unnumbered} |
|                       |                      |                       |
|                       | \[95% Confidence     |                       |
|                       | Interval\]           |                       |
+-----------------------+----------------------+-----------------------+
| Device-Related        | 13.8% (6.1, 25.4)    | 8                     |
|                       |                      |                       |
| Major Adverse Events  | 17.2% (8.6, 29.4)    | 10                    |
|                       |                      |                       |
| 48-hours              | 17.2% (8.6, 29.4)    | 10                    |
|                       |                      |                       |
| 30-days               | 17.2% (8.6, 29.4)    | 10                    |
|                       |                      |                       |
| 6-month               |                      |                       |
|                       |                      |                       |
| Most recent follow-up |                      |                       |
+-----------------------+----------------------+-----------------------+
| Procedure-Related     | 55.2% (41.5, 68.3)   | 32                    |
|                       |                      |                       |
| Major Adverse Events  | 56.9% (43.2, 69.8)   | 33                    |
|                       |                      |                       |
| 48-hours              | 58.6% (44.9, 71.4)   | 34                    |
|                       |                      |                       |
| 30-days               | 58.6% (44.9, 71.4)   | 34                    |
|                       |                      |                       |
| 6-month               |                      |                       |
|                       |                      |                       |
| Most recent follow-up |                      |                       |
+-----------------------+----------------------+-----------------------+
| Minor Adverse Events  | 27.6% (16.7, 40.9)   | 16                    |
|                       |                      |                       |
| 48-hours              | 37.9% (25.5, 51.6)   | 22                    |
|                       |                      |                       |
| 30-days               | 41.4% (28.6, 55.1)   | 24                    |
|                       |                      |                       |
| 6-month               | 60.3% (46.6, 73.0)   | 35                    |
|                       |                      |                       |
| Most recent follow-up |                      |                       |
+-----------------------+----------------------+-----------------------+
| Device-embolization   | 1.7% (0.0, 9.2)      | 1                     |
|                       |                      |                       |
| Percutaneous          | 0.0% (0.0, 6.2)      | 0                     |
| retrieval             |                      |                       |
|                       |                      |                       |
| Surgical retrieval    |                      |                       |
+-----------------------+----------------------+-----------------------+
| Device Malposition    | 8.6% (2.9, 19.0)     | 5                     |
|                       |                      |                       |
| No intervention       | 0.0% (0.0, 6.2)      | 0                     |
|                       |                      |                       |
| Intervention required |                      |                       |
+-----------------------+----------------------+-----------------------+
| Device Fracture       | 1.7% (0.0, 9.2)      | 1                     |
|                       |                      |                       |
| 48-hours              | 3.4% (0.4, 11.9)     | 2                     |
|                       |                      |                       |
| 30-days               | 5.2% (1.1, 14.4)     | 3                     |
|                       |                      |                       |
| 6-month               | 20.7% (11.2, 33.4)   | 12                    |
|                       |                      |                       |
| Most Recent follow-up |                      |                       |
+-----------------------+----------------------+-----------------------+
| Device Fracture       | ###  {#              | 12                    |
|                       | section .unnumbered} |                       |
| Associated with       |                      | 0                     |
| adverse event         | ### 20.              |                       |
|                       | 7% (11.2, 33.4) {#se |                       |
| No adverse events     | ction-1 .unnumbered} |                       |
|                       |                      |                       |
|                       | 0.0% (0.0, 6.2)      |                       |
+-----------------------+----------------------+-----------------------+
| Cardiac Perforation   | ###                  | 1                     |
|                       | 1.7% (0.0, 9.2) {#se |                       |
|                       | ction-2 .unnumbered} |                       |
+-----------------------+----------------------+-----------------------+
| Blood Loss Requiring  | ### 62.              | 36                    |
| Transfusion           | 1% (48.4, 74.5) {#se |                       |
|                       | ction-3 .unnumbered} |                       |
+-----------------------+----------------------+-----------------------+

## Potential Adverse Events

Placement of the CardioSEAL involves using standard interventional
cardiac catheterization techniques. Complications commonly associated
with these procedures include, but are not limited to:

-   Air Embolus

-   Allergic dye reaction

-   Anesthesia reactions

-   Apnea

-   Arrhythmia

-   Death

-   Fever

-   Headache / Migraines

-   Hematoma and/or Pseudoaneurysm including blood loss requiring
    transfusion

-   Hypertension; Hypotension

-   Infection including Endocarditis

-   Perforation of Vessel or Myocardium

-   Stroke / Transient Ischemic Attack

-   Thromboembolic events

-   Valvular regurgitation.

## Observed Device Malfunctions

There were four reports of a kink in the delivery system, identified
during the device placement, and one report of a kink in the delivery
system during loading of the device. There were no clinical sequelae
associated with any of these device malfunctions.

# CLINICAL STUDIES

## Study Design/Objective

The multi-center clinical trial conducted by Children's Hospital,
Boston, Massachusetts, is a prospective, non-randomized trial studying
the use of the CardioSEAL Septal Occlusion system to close a variety of
hemodynamically significant defects. The risks of surgical closure for
the patients enrolled in this trial were considered sufficient to
justify the known and potentially unknown risks of transcatheter closure
with the CardioSEAL device. The study (referred to as the High-risk
study) is ongoing and is summarized below. Data from patients undergoing
VSD closure were extracted from this study.

## Patient Entry

Patients were eligible for enrollment in the High Risk Study if they had
a defect(s) of sufficient size to require closure, but were considered
to be at high risk for surgical closure, due to either complex medical
or cardiac disease. An independent peer review group determined whether
a patient should be enrolled into the trial based on the following
criteria:

-   the patient had a type of defect that was technically difficult or
    impossible to close surgically, such that the surgical risks were
    sufficient to justify the known and potential unknown risks of the
    device, or

-   the patient's overall medical condition was such that the surgical
    risks were sufficient to justify the known and potential unknown
    risks of the device.

## Methods

After enrollment, patients underwent cardiac catheterization. Position
and size of the defect were confirmed by angiography. A hemodynamic
assessment was performed pre-implant, and after test occlusion of the
defect with a balloon. When these data suggested that the defect
contributed to unfavorable hemodynamics and was feasible for
transcatheter closure, device placement proceeded. Patients received
aspirin, 1mg/kg/day, rounded to the nearest half tablet of 80 mg size,
for at least six months following the procedure. Patients were seen for
follow up assessments at 1, 6, 12 and 24 months.

## Primary Endpoints

A 6-category ordinal scale (clinical status scale) was used to measure
clinical status. The Clinical Status Scale grouped patients into eight
different categories (right to left shunt, left to right shunt,
anatomic, systemic embolic, hemodynamic compromise not due to shunt,
arrhythmia, elevated PVR, and medical illness). The left to right shunt
category was the category most closely related to the patient's
indication for device closure of the VSD. This scale is shown in Table 2
below. The scale took values from 0 to 5, and was constructed so that an
improvement by one category (e.g., from category 1 to category 2, or
from 2 to 3, etc.) would be considered clinically meaningful. Deceased
patients and those who have had their device explanted receive a value
of --1). Data used in the construction of the scale were measured
objectively by diagnostic laboratory tests, documented clinical status,
or echocardiography. The data were collected prospectively before device
implantation, at discharge from the hospital, and at each follow-up
visit, so that patient classification at each time point could be
implemented using a computer algorithm.

  -------------- ------------- ------------- -------------- ---------- -------- -----------
  **Clinical                                                                    
  Status                                                                        
  Scale^1^ --                                                                   
  Table 2**                                                                     

  **Category**   **0**         **1**         **2**          **3**      **4**    **5**

  L to R shunt   Ventilator    Heart         Left           moderate   small    trivial or
                 dependent     failure,      ventricular    shunt      shunt    no shunt
                 and/or        symptomatic   volume                             
                 intractable                 overload,                          
                 CHF                         significant/                       
                                             large shunt                        
  -------------- ------------- ------------- -------------- ---------- -------- -----------

1\. Deceased patients and those who have had their device explanted are
rated as --1 on the Clinical Status Scale.

Patients with prior placement of a pulmonary artery band to limit the
degree of left to right shunting are categorized, where possible,
according to the estimated anatomic size of the defect.

Additionally an assessment of the echocardiographic closure status was
made at each time point both at the evaluating facility, and by an
unaffiliated core laboratory. Residual flow was assessed using Doppler
color flow mapping, and graded using the following guidelines:

-   **\"Trivial\" to \"Absent\":** barely detectable or no detectable
    residual color flow through the defect. If flow is present, it is a
    single color flow jet, well-circumscribed, with a proximal jet width
    measuring less than 1 mm in diameter in all views.

-   **\"Small\":** single color flow jet, well-circumscribed, and
    measuring 1-2mm (maximal proximal width) in all views in infants and
    children weighing less than 20 kg, or between 1 and 3 mm in diameter
    in larger children and adults.

-   **\"More than small\":** single color flow jet, well-circumscribed,
    measuring greater than 2 mm in diameter in all views in infants and
    children weighing less than 20 kg, or greater than 3 mm in diameter
    in all views in larger children and adults.

## Results

At the time the VSD data was analyzed, 74 patients with no additional
anatomic lesions were enrolled in the study for closure of a VSD.
Enrollment occurred at two investigational sites. Thirteen of these
patients did not have a device implant attempted, in most cases because
the defect was smaller than anticipated.

Device placement was successful in 57 of 58 patients (98%) in whom an
implant was attempted. Multiple procedures were performed in 6 patients,
and multiple devices were implanted in 26 patients for a total of 107
implanted devices. There were 4 device embolizations which all occurred
in the same patient while attempting to close a large post operative
residual defect. All 4 were retrieved at catheterization. No other
embolizations occurred.

The types of VSD defects closed with a CardioSEAL device were:
congenital muscular (26); and post-operative (31). Seventeen patients
(23%) had previously undergone placement of a pulmonary artery band.

Among the 57 patients implanted with a CardioSEAL device, there were 24
(42%) males and 33 (58%) females. The age of the patients ranged from
0.3 years to 70.1 years, with a median age of 3.7 years.

Four patients had devices that were explanted, 2 at the time of a heart
transplant, 1 at a Fontan surgery performed after a failed septation,
and 1 at a catheterization during which an unsuccessful attempt was made
to close a large residual defect.

Among the 57 implanted patients, 44 (77%) could be assessed according to
the Clinical Status Scale by Lesion at both pre-implantation and at the
6-month follow-up time point. In this group, the median change in scale
value was an increase of 2 categories (p\<0.0001 compared to no
improvement); 84.1% of the procedures were successful at 6 months (95%CI
\[69.9, 93.4\]). Six patients were in a lower clinical status category
than prior to implantation; this includes 3 patients who died and 2 who
had their devices explanted. Success rates at 6 months did not differ
for patients with congenital defects (85.7%, \[63.7, 97.0\]) and those
with postoperative defects (82.6% \[61.2, 95.0\]). Patients under 10
years of age had a higher rate of success than those between 10 and 30
(p=0.008).

Fifty-three of the 57 implanted patients (93%) could be evaluated
according to the Clinical Status Scale by Patient at both
pre-implantation and at the 6 month follow-up visit. The median change
in scale value was an increase of 2 categories (p \<0.0001); 71.7%
\[57.7, 83.2\] of the procedures were successful at 6 months.

Echocardiographic closure status changed from a median of 3 (more than
small residual flow) prior to implantation to a median of 2 (small
residual flow) at the 6-month time point (p\<0.0001).

## Table 3 - Baseline Demographics, Principal Effectiveness Measures, & Principal Safety Measures {#table-3---baseline-demographics-principal-effectiveness-measures-principal-safety-measures .unnumbered}

+-----------------------+---+---------+---+-------+---+-------+-------------+
| **Patient Enrollment  |   |         |   |       |   |       |             |
| (number of            |   |         |   |       |   |       |             |
| patients)**           |   |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Enrolled              |   |         | 7 |       |   |       |             |
|                       |   |         | 4 |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Occluder Implant not  |   |         | 1 |       |   |       |             |
| Attempted^1^          |   |         | 3 |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Occluder Implant      |   |         | 6 |       |   |       |             |
| Attempted^2^          |   |         | 1 |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Occluder(s) Implanted |   |         | 5 |       |   |       |             |
|                       |   |         | 7 |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Single Procedure      |   |         | 5 |       |   |       |             |
|                       |   |         | 2 |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Multiple              |   |         | 6 |       |   |       |             |
| Procedures^3^         |   |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| More than One         |   |         | 2 |       |   |       |             |
| Occluder Placed^4^    |   |         | 5 |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
|                       |   |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| **Principal           |   |         |   |       |   |       |             |
| Effectiveness         |   |         |   |       |   |       |             |
| Measures**            |   |         |   |       |   |       |             |
|                       |   |         |   |       |   |       |             |
| **(n=57, patients     |   |         |   |       |   |       |             |
| with CardioSEAL       |   |         |   |       |   |       |             |
| Device)**             |   |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
|                       |   | Percent |   | M     |   | p-    | Number of   |
|                       |   |         |   | edian |   | value | Patients    |
|                       |   | \[95%   |   | Scale |   |       |             |
|                       |   | C.I.\]  |   | Value |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Technical Success^5^  |   | 71.7%   |   |       |   |       | 53          |
|                       |   | \[57.7, |   |       |   |       |             |
|                       |   | 83.2\]  |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Pre-implant Clinical  |   |         |   | 1     |   | \-    | 56          |
| Status Score          |   |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Post-implant clinical |   |         |   | 3.5   |   | \<    | 54          |
| Status Score^6^       |   |         |   |       |   | .0001 |             |
|                       |   |         |   | 4     |   |       | 56          |
| 6-month               |   |         |   |       |   | \<    |             |
|                       |   |         |   |       |   | .0001 |             |
| Most recent follow-up |   |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Pre-implant Echo      |   |         |   | 3     |   | \-    | 34          |
| Closure Score^7,8^    |   |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Post-implant Echo     |   |         |   | 2     |   | \<    | 22          |
| Closure Score         |   |         |   |       |   | .0001 |             |
|                       |   |         |   | 2     |   |       | 28          |
| 6-month               |   |         |   |       |   | \<    |             |
|                       |   |         |   |       |   | .0001 |             |
| Most recent follow-up |   |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| **Principal Safety    |   |         |   |       |   |       |             |
| Measures**            |   |         |   |       |   |       |             |
|                       |   |         |   |       |   |       |             |
| **(n=58, patients     |   |         |   |       |   |       |             |
| with implant          |   |         |   |       |   |       |             |
| attempted)**          |   |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
|                       | P |         |   |       | N |       |             |
|                       | e |         |   |       | u |       |             |
|                       | r |         |   |       | m |       |             |
|                       | c |         |   |       | b |       |             |
|                       | e |         |   |       | e |       |             |
|                       | n |         |   |       | r |       |             |
|                       | t |         |   |       | o |       |             |
|                       |   |         |   |       | f |       |             |
|                       | \ |         |   |       | P |       |             |
|                       | [ |         |   |       | a |       |             |
|                       | 9 |         |   |       | t |       |             |
|                       | 5 |         |   |       | i |       |             |
|                       | % |         |   |       | e |       |             |
|                       | C |         |   |       | n |       |             |
|                       | . |         |   |       | t |       |             |
|                       | I |         |   |       | s |       |             |
|                       | . |         |   |       |   |       |             |
|                       | \ |         |   |       |   |       |             |
|                       | ] |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Major Adverse         | 6 |         |   |       | 3 |       |             |
| Events^9^             | 3 |         |   |       | 7 |       |             |
|                       | . |         |   |       |   |       |             |
| 48-hours              | 8 |         |   |       | 4 |       |             |
|                       | % |         |   |       | 1 |       |             |
| 30-days               | ( |         |   |       |   |       |             |
|                       | 5 |         |   |       | 4 |       |             |
| 6-month               | 0 |         |   |       | 3 |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | 6 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 0 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
|                       |   |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | 0 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | % |         |   |       |   |       |             |
|                       | ( |         |   |       |   |       |             |
|                       | 5 |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 3 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 8 |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 9 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
|                       |   |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | 4 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | % |         |   |       |   |       |             |
|                       | ( |         |   |       |   |       |             |
|                       | 6 |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 0 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 8 |         |   |       |   |       |             |
|                       | 4 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Minor Adverse Events  | 2 |         |   |       | 1 |       |             |
|                       | 7 |         |   |       | 6 |       |             |
| 48-hours              | . |         |   |       |   |       |             |
|                       | 6 |         |   |       | 2 |       |             |
| 30-days               | % |         |   |       | 2 |       |             |
|                       | ( |         |   |       |   |       |             |
| 6-month               | 1 |         |   |       | 2 |       |             |
|                       | 6 |         |   |       | 4 |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 4 |         |   |       |   |       |             |
|                       | 0 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 9 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
|                       |   |         |   |       |   |       |             |
|                       | 3 |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 9 |         |   |       |   |       |             |
|                       | % |         |   |       |   |       |             |
|                       | ( |         |   |       |   |       |             |
|                       | 2 |         |   |       |   |       |             |
|                       | 5 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 5 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 5 |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 6 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
|                       |   |         |   |       |   |       |             |
|                       | 4 |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 4 |         |   |       |   |       |             |
|                       | % |         |   |       |   |       |             |
|                       | ( |         |   |       |   |       |             |
|                       | 2 |         |   |       |   |       |             |
|                       | 8 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 6 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 5 |         |   |       |   |       |             |
|                       | 5 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Device-related        | 1 |         |   |       | 1 |       |             |
| Adverse Events        | . |         |   |       |   |       |             |
|                       | 7 |         |   |       | 5 |       |             |
| Embolization          | % |         |   |       |   |       |             |
|                       | ( |         |   |       | 1 |       |             |
| Delivery System       | 0 |         |   |       | 2 |       |             |
|                       | . |         |   |       |   |       |             |
| Fractures             | 0 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 9 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 2 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
|                       |   |         |   |       |   |       |             |
|                       | 8 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 6 |         |   |       |   |       |             |
|                       | % |         |   |       |   |       |             |
|                       | ( |         |   |       |   |       |             |
|                       | 2 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 9 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | 9 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 0 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
|                       |   |         |   |       |   |       |             |
|                       | 2 |         |   |       |   |       |             |
|                       | 0 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | % |         |   |       |   |       |             |
|                       | ( |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 2 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 3 |         |   |       |   |       |             |
|                       | 3 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 4 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Procedure-related     | 8 |         |   |       | 4 |       |             |
| Adverse Events ^10^   | 4 |         |   |       | 9 |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 5 |         |   |       |   |       |             |
|                       | % |         |   |       |   |       |             |
|                       | ( |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | 2 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 6 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 9 |         |   |       |   |       |             |
|                       | 2 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Blood loss requiring  | 6 |         |   |       | 3 |       |             |
| transfusion           | 2 |         |   |       | 6 |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | % |         |   |       |   |       |             |
|                       | ( |         |   |       |   |       |             |
|                       | 4 |         |   |       |   |       |             |
|                       | 8 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 4 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | 4 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 5 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| Vascular              | 1 |         |   |       | 9 |       |             |
|                       | 5 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 5 |         |   |       |   |       |             |
|                       | % |         |   |       |   |       |             |
|                       | ( |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 3 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 2 |         |   |       |   |       |             |
|                       | 7 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 4 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+
| ANY Adverse Event     | 9 |         |   |       | 5 |       |             |
|                       | 8 |         |   |       | 7 |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 3 |         |   |       |   |       |             |
|                       | % |         |   |       |   |       |             |
|                       | ( |         |   |       |   |       |             |
|                       | 9 |         |   |       |   |       |             |
|                       | 0 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 8 |         |   |       |   |       |             |
|                       | , |         |   |       |   |       |             |
|                       | 1 |         |   |       |   |       |             |
|                       | 0 |         |   |       |   |       |             |
|                       | 0 |         |   |       |   |       |             |
|                       | . |         |   |       |   |       |             |
|                       | 0 |         |   |       |   |       |             |
|                       | ) |         |   |       |   |       |             |
+-----------------------+---+---------+---+-------+---+-------+-------------+

1.  Occluder implant not attempted: defect smaller than anticipated
    (12), unfavorable anatomy (1).

2.  3 patients received a StarFLEX device (which is not the subject of
    this PMA); 1 attempted but not placed.

3.  Multiple procedures: 2 procedures (4), 3 procedures (2).

4.  More than one occluder placed: 2 occluders (11), 3 occluders (8), 4
    occluders (3), 5 occluders (2), 7 occluders (1).

5.  Technical success: a one category improvement from pre-implantation
    score at 6 month follow-up.

6.  Clinical Status Score: A 6-category ordinal scale used to measure
    clinical status was developed for the High-Risk Study. The scale
    takes values from 0 to 5, & was constructed so that an improvement
    by 1 category (e.g., 1 to 2, etc.) is considered clinically
    meaningful. All data used in the construction of the scale are
    measured objectively by diagnostic lab tests, documented clinical
    status, and/or echocardiography. Data are collected pre-implant, at
    discharge and at each follow-up visit.

7.  Echo Closure Score: A 3-category ordinal scale used to measure
    residual flow, categorized as (1) trivial to absent, (2) small, (3)
    more than small.

8.  Only patients with echocardiographic images adequate to assess flow
    are included.

9.  Major Adverse Events: equals serious and moderately serious adverse
    events. Minor adverse events are all those not considered serious or
    moderately serious.

10. Includes all implantation and catheterization procedure related
    events.

# HOW SUPPLIED

The occluder and delivery system are packaged separately and are
supplied sterile. Product is sterilized with ethylene oxide.

# DIRECTIONS FOR USE

## Detailed Product Description

The CardioSEAL Septal Occlusion System consists of two primary
components. The CardioSEAL (Occluder) is comprised of a metal alloy
(MP35N) framework to which polyester fabric material has been attached.

From the center of the CardioSEAL, a small wire with a pin at its end
extrudes out at approximately 90 degrees to the plane of the CardioSEAL.
The CardioSEAL is attached to sutures through a loading funnel. The
loader should always be connected via sutures to the side of the
CardioSEAL opposite the side from which the pin wire extrudes.

The delivery catheter is comprised of a coaxial catheter shaft through
which a spring guide travels, connected to a solid control rod. At the
proximal end of the control rod, a control handle is connected to an
inner control wire, which courses through the spring guide to the distal
end of the catheter shaft, where it terminates within a small tubular
sleeve. The control wire terminates at the distal end in a pin, for
attachment to its mate on the CardioSEAL. When retracted, the pin slides
inside the sleeve. The distal end of the catheter terminates in a pod.
Retraction on the control rod moves the sleeve into the pod. Refer to
figure 1 for an illustration of the delivery system and CardioSEAL.

## CardioSEAL Size Selection and Inspection

Selection of an appropriately sized CardioSEAL should be based upon
measuring the defect diameter through the use of a sizing balloon
(stretched defect diameter -- SDD), procedural angiography and/or
Transesophageal echocardiography, unless the size of the defect is known
from the medical record. It is recommended that the CardioSEAL to
Stretched Defect Diameter ratio (O:SDD) be 1.7-2.0:1, and that the area
containing the target defect be large enough to allow the CardioSEAL to
fully deploy. The defect and surrounding structures should be fully
examined in multiple planes to assure proper sizing of the CardioSEAL.

The Right Femoral Vein or Right Internal Jugular vein is recommended for
vascular access although physicians should consider the VSD location and
the route of introducer sheath travel relative to the potential for
access in selecting the venous access site.

An 11F, 75cm long, hemostasis control introducer sheath with NIH type
curve is recommended for CardioSEAL delivery. Sheath curve shape may
need modification based on individual patient conditions and defect
location. As the use of long sheaths represents a potential risk of air
embolus, care should be taken to insure adequate irrigation and
'backfilling' of the sheath with saline during removal of the dilator in
order to avoid air entry.

A 14F or 16F short introducer sheath may be placed coaxially over the
long introducer sheath prior to long sheath insertion if the physician
believes the circumstances of the case raise the potential for device
retrieval after attempted placement.

Prior to use, inspect the delivery system and CardioSEAL for signs of
damage, such as kinks or bends in delivery wire or framework of the
CardioSEAL. Check for secure attachment of the fabric to the framework.

Manipulate the delivery system and actuate the control handle to ensure
that the attach release pin exits and retracts into the sleeve, and that
the spring guide wire exits and retracts into the pod.

## Preparation for Delivery

*NOTE:* Attachment and loading of the CardioSEAL into the delivery
catheter should not occur until

a\. the defect has been determined to be of appropriate size and
position to accommodate the CardioSEAL, and

b\. access to the defect with an appropriate French size and length
introducer sheath has been obtained.

*NOTE:* NMT Medical recommends that the CardioSEAL family of Septal
Occluders be delivered to the target defect via a Cook 10F (minimum)
style transseptal length introducer sheath with radiopaque marker band.

## General Description of the CardioSEAL Occluder and Front Loading Delivery System with Qwik load adaptation

The CardioSEAL Occluder incorporates a loading system, called Qwik
Load that serves to transfer the loaded Occluder into the delivery
sheath. The Qwik Load Assembly is comprised of a Funnel Pod that directs
the Occluder into a tubular section called the Funnel Pod Tube. The
Funnel Pod Tube is protected by a clear Outer Jacket that acts as a stop
to prevent the occluder from being pulled out the end. The Funnel Pod
has luer threads on the outer rim for connection to the Irrigation
Toughy on the delivery catheter to facilitate irrigation of the Occluder
prior to insertion in the sheath. See Figure 1 for a diagram of the
Occluder and associated nomenclature.

![](media/image1.png){width="4.090277777777778in"
height="1.511111111111111in"}

**Figure 1**

  -------- --------------------------- -------- ---------------------------
  1\.      Occluder                    4\.      Funnel Pod Tube

  2\.      Suture                      5\.      Outer Jacket

  3\.      Funnel Pod                  6\.      Suture button
  -------- --------------------------- -------- ---------------------------

> The Delivery System with Qwik Load (Figure 2) is a coaxial catheter
> that facilitates attachment of the Occluder and transfer of the
> Occluder from the Funnel Pod to a previously placed and irrigated 10F
> (minimum) sheath.

![](media/image2.png){width="4.2625in" height="1.4659722222222222in"}

Figure 2

  -------- --------------------------- -------- ---------------------------
  1\.      Pin Wire Control Handle     6\.      Irrigation Toughy Cap

  2\.      Control Rod                 7\.      Blue Catheter Shaft

  3\.      Locking Collar              8\.      Spring Guide

  4\.      Control Toughy              9\.      Sleeve

  5\.      Irrigation Toughy           10\.     Pin Wire
  -------- --------------------------- -------- ---------------------------

## Attachment and Loading of the Occluder to the FL Delivery System

> Open and remove components from the Occluder and Delivery System
> packages and inspect for obvious signs of damage from shipment. If
> damage is suspected, do not use. Place the Occluder with Qwik Load
> Assembly into sterile saline for irrigation.
>
> **Figure 3:** Recheck Irrigation Toughy on the blue delivery catheter
> shaft and, if loose, gently tighten to prevent it from slipping off
> the catheter and to keep it out of the way until required for
> irrigation later in the loading process.

![](media/image3.jpeg){width="4.001388888888889in"
height="1.2326388888888888in"}

**Figure 3**

> Loosen the locking collar on the delivery system and fully extend the
> spring guide from the tip of the blue catheter shaft. This will
> facilitate irrigation of the delivery system and allow for easier
> attachment of the Occluder.
>
> Irrigate the delivery system via the side port on the control toughy.
> Remember to tighten the locking collar around the control rod to
> facilitate downstream irrigation of the catheter shaft portion. Leave
> locking collar in the tightened position to fix relationship of blue
> catheter to spring guide.
>
> Using the Pin Wire Control Handle, extrude the Pin Wire about 2-3 mm
> out from the sleeve.
>
> **Figure 4:** Holding the Occluder, insert the Occluder pin into the
> sleeve of the delivery system, and then retract delivery system pin
> wire back into the sleeve using the Pin Wire Control Handle.

![](media/image4.wmf){width="4.000694444444444in" height="1.2875in"}

**Figure 4**

> Lightly pivot the occluder to assure that pivoting mechanism is
> operating. The Occluder is now securely attached to the delivery
> system and ready for collapsing into the Qwik Load assembly.
>
> **[Loading of the Occluder]{.underline}**
>
> Irrigate the Funnel Pod loader with the Irrigation Toughy with normal
> saline. DO NOT REMOVE LOADER JACKET.
>
> **Figure 5:** While holding the blue catheter shaft steady, pull the
> suture button to draw the distal arms of the Occluder into a fully
> collapsed position.

![](media/image5.png){width="4.00625in" height="1.6659722222222222in"}

**Figure 5**

> **Figure 6:** While holding light tension on both the suture button
> and the blue catheter, gently advance the Funnel Pod over the
> collapsed Occluder arms and then over the proximal arms.

![](media/image6.jpeg){width="3.9965277777777777in"
height="1.288888888888889in"}

**Figure 6**

> **Figure 7:** Pull gently until resistance is felt when the collapsed
> Occluder reaches the end of the Funnel Pod Tube (visible through Outer
> Jacket).

![](media/image7.jpeg){width="4.004861111111111in"
height="1.3020833333333333in"}

**Figure 7**

> **Figure 8:** Loosen the locking collar on the delivery system and
> advance the blue catheter into the Funnel Pod Tube until the tip of
> the blue catheter is adjacent to the collapsed (or within 1mm)
> Occluder. Then, retighten locking collar.

![](media/image8.jpeg){width="4.001388888888889in"
height="1.1861111111111111in"}

**Figure 8**

> **Figure 9:** Cut the Suture and remove and discard Suture and Suture
> Button.

![](media/image9.png)

**Figure 9**

> **Figure 10:** Remove and discard Outer Jacket (attached by luer
> connection).

![](media/image10.jpeg){width="4.0055555555555555in"
height="1.167361111111111in"}

**Figure 10**

> **Figure 11:** The Occluder should now be fully collapsed inside the
> Funnel Pod. Note how the blue catheter is adjacent to the Occluder.

![](media/image11.jpeg){width="3.995833333333333in"
height="1.2013888888888888in"}

**Figure 11**

> **Figure 12:** Loosen the Irrigation Toughy and advance it over the
> blue catheter, connecting it securely to the Funnel Pod.

![](media/image12.jpeg){width="3.9965277777777777in"
height="1.2833333333333334in"}

**Figure 12**

> Irrigate the Funnel Pod thoroughly by attaching a syringe to the 3-way
> stopcock. First, loosen the toughy portion of the Irrigation Toughy
> and irrigate proximally toward the catheter hub. Tighten the toughy
> portion of Irrigation Toughy and irrigate distally through the Funnel
> Pod, which contains the collapsed Occluder. The Occluder is now ready
> to be transferred into the previously placed delivery sheath.
> *Re-irrigation of the delivery sheath prior to Occluder insertion is
> recommended; especially if the sheath has been inserted for some time
> prior to implant transfer.*
>
> **Figure 13:** Insert the Funnel Pod Tube into the hub of the
> previously placed long sheath. Advance it (the Funnel Pod Tube)
> through the sheath hub and into the sheath, until resistance is met.
> The Occluder is now ready to be transferred into the sheath, which is
> in place through the defect.

![](media/image13.jpeg){width="4.003472222222222in" height="1.2875in"}

**Figure 13**

## Insertion

*NOTE:* As previously discussed in Section C, Preparation, Note B, an
introducer sheath of sufficient French size for the CardioSEAL and of
adequate length to reach the target defect should have been placed via
the venous system across the defect.

### Reposition sheath across the VSD so that the distal tip of the sheath is approximately 1cm into the distal side of the VSD (Figure 14). Thoroughly irrigate the previously placed introducer sheath to minimize risk of air entry and air embolus. 

Figure 14![](media/image14.png){width="3.3152777777777778in"
height="3.120138888888889in"}

### Transfer Occluder into the sheath using the delivery catheter to advance it out of the loader, and advance until the Occluder is at the tip of the sheath (Figure 15)

Figure 15![](media/image15.png){width="2.448611111111111in"
height="2.515972222222222in"}

### Recheck sheath tip position to verify location on distal side of VSD. Holding the sheath and Occluder steady, loosen the locking collar and retract the delivery catheter approximately 10 cm away from the implant (Figure 16).

Figure 16![](media/image16.png){width="2.654166666666667in"
height="2.6006944444444446in"}

### Holding the sheath steady, advance the distal set of CardioSEAL arms out of the sheath by advancing the blue catheter forward. Alternatively, open distal set of CardioSEAL arms by retracting sheath off of the distal arms. Under fluoroscopy and transesophageal echo, ascertain that all four distal CardioSEAL arms have fully deployed and are intact (Figure 17).

![](media/image17.png){width="2.952777777777778in"
height="2.464583333333333in"}

Figure 17

### Holding the sheath and catheter steady, retract entire sheath -- catheter ‑ CardioSEAL until the distal CardioSEAL arms approximate or engage the distal wall of the VSD (Figure 18).

Figure 18![](media/image18.png){width="2.9305555555555554in"
height="2.5069444444444446in"}

### Once approximated or engaged, retract CardioSEAL further to slightly flex the CardioSEAL arms. Retract sheath off of proximal CardioSEAL arms while maintaining position in the VSD. This will release the proximal arms of the CardioSEAL to engage the proximal VSD wall (Figure 19).

Figure 19![](media/image19.png){width="2.9784722222222224in"
height="2.729861111111111in"}

### Allow delivery catheter and sheath to assume a neutral (i.e. no retraction) position and confirm correct placement of all arms on appropriate sides of the VSD.

### Once proper positioning is confirmed, advance the pin from the sleeve using the control handle at the proximal end of the delivery system. This will release the CardioSEAL from the delivery system (Figure 20).

Figure 20![](media/image20.png){width="3.1006944444444446in"
height="2.682638888888889in"}

### Remove delivery system from sheath.

# PATIENT INFORMATION

The following counseling information should be provided to the patient:

-   Patients should be reminded of the importance of adhering to their
    aspirin and endocarditis prophylaxis regimens.

-   If an MRI is required, the patient should inform MRI staff of the
    presence of the CardioSEAL.

-   Patients should be encouraged to contact their physician if they
    have any questions or concerns

-   A patient brochure is available and is entitled: "A Patient's Guide
    to Transcatheter Hole Closure of a Ventricular Septal Hole using The
    CardioSEAL Septal Occlusion System."