##  {#section .unnumbered}

##  {#section-1 .unnumbered}

+---------------------+---------------------------------+--------------+
|                     |                                 |              |
+---------------------+---------------------------------+--------------+
|                     |                                 |              |
+---------------------+---------------------------------+--------------+
|                     |                                 |              |
+---------------------+---------------------------------+--------------+
| ###  {#sec          |                                 |              |
| tion-2 .unnumbered} |                                 |              |
+---------------------+---------------------------------+--------------+
|                     |                                 |              |
+---------------------+---------------------------------+--------------+
|                     |                                 |              |
+---------------------+---------------------------------+--------------+
|                     |                                 |              |
+---------------------+---------------------------------+--------------+
|                     |                                 |              |
+---------------------+---------------------------------+--------------+
|                     |                                 |              |
+---------------------+---------------------------------+--------------+

> C for 60 seconds with power output between 25W and 50W.

+--------+------------------------+---+-------------------------------+
|        |                        |   | -                             |
|        |                        |   | -                             |
|        |                        |   | -                             |
|        |                        |   | -                             |
+--------+------------------------+---+-------------------------------+
|        |                        |   | -                             |
|        |                        |   | -                             |
|        |                        |   | -                             |
|        |                        |   | -                             |
|        |                        |   | -                             |
|        |                        |   | -                             |
+--------+------------------------+---+-------------------------------+
|        |                        |   | -                             |
|        |                        |   | -                             |
+--------+------------------------+---+-------------------------------+
|        |                        |   | -                             |
|        |                        |   | -                             |
|        |                        |   | -                             |
|        |                        |   | -                             |
|        |                        |   | -                             |
+--------+------------------------+---+-------------------------------+

  ------------- ----------------- ---------------- ----------- -----------
                                                               

                                                               

                                                               

                                                               
  ------------- ----------------- ---------------- ----------- -----------

  -------------------------------------- --------------- ----------------
                                                         

                                                         

                                                         

                                                         

                                                         

                                                         

                                                         

                                                         

                                                         

                                                         
  -------------------------------------- --------------- ----------------

##  {#section-3 .unnumbered}

## 

10. 
11. 

> Table 2, Clinical Success

  -------------------------------------- --------------- ----------------
                                                         

                                                         

                                                         

                                                         

                                                         

                                                         

                                                         

                                                         

                                                         

                                                         
  -------------------------------------- --------------- ----------------

#  {#section-5 .unnumbered}

**DEVICE LABELING**

# Cardima REVELATION^®^ Tx Cardiac Ablation System {#cardima-revelation-tx-cardiac-ablation-system .unnumbered}

> ![](media/image1.png){width="0.49583333333333335in"
> height="0.19652777777777777in"} Contents sterile in unopened,
> undamaged package
>
> ![](media/image2.png){width="0.2465277777777778in"
> height="0.23819444444444443in"} CAUTION: This device is intended for
> one use only. Do not re-sterilize or re-use the device.
>
> CAUTION: Federal (U.S.A) Law restricts this device to sale by, or on
> the order of a physician.

## Description {#description .unnumbered}

The Cardima^®^ REVELATION^®^ Tx Microcatheter System consists of a
single use, steerable, eight-electrode ablation microcatheter (3.7F),
the REVELATION^®^ Tx, with an atraumatic, flexible, non-electrically
active tip, and a single use, deflectable NavAblator™ \"hot tip\" (4mm)
ablation catheter (8F) with an electrically active tip. Both catheters
incorporate thermocouple sensors for temperature feedback.

> ![](media/image3.wmf)

#### Figure 1, Cardima REVELATION^®^ Tx Microcatheter {#figure-1-cardima-revelation-tx-microcatheter .unnumbered}

![](media/image4.wmf){width="5.961805555555555in"
height="1.1784722222222221in"}

#### Figure 2, Cardima^®^ NavAblator™ {#figure-2-cardima-navablator .unnumbered}

# Intended Use {#intended-use .unnumbered}

The Cardima^®^ Inc., REVELATION^®^ Tx Microcatheter RF Ablation System
is indicated for the treatment of Atrial Fibrillation in patients with
drug refractory paroxysmal atrial fibrillation by creating a set of
continuous linear lesions along the lateral and septal walls and along
the isthmus in the right atrium.

The REVLATION^®^ Tx is intended for the creation of continuous linear
lesions for the purpose of interrupting arrhythmia pathways.

The NavAblator™ is intended for the creation of linear lesions at the
isthmus for the purpose of interrupting arrhythmia pathways.

## Contraindications {#contraindications .unnumbered}

-   This procedure is contraindicated in patients with active systemic
    infection.

-   The catheters in this system should not be used to create lesions in
    conditions where the catheter would be unsafe (e.g., intracardiac
    thrombus).

## Warnings  {#warnings .unnumbered}

• This device is not intended for ablation from within the coronary
vasculature.

• Use of RF energy may interfere with proper function of pacemakers and
implantable cardioverter/defibrillators. Refer to PPM/ICD manufacturer's
instruction on use of RF energy with these devices mentioned.

• Never advance or retract device against unknown resistance or damage
to device or its components may occur.

• Improper handling or use including reuse of this device may result in
device failure and/or possible complications.

## Precautions  {#precautions .unnumbered}

• Catheter placement should be accomplished under fluoroscopic imaging.

• The long-term risks of fluoroscopic exposure have not been
established.

• The long-term risks of radiofrequency ablation have not been
established.

• Use in conjunction with the Tx SELECT™ switchbox and Tx Catheter
Cable. (See technical specification and requirements)

• Excessive bending or kinking of the device may cause damage to the
device or its components.

• Always consult the RF-Generator Operating Manual and follow
precautions prior to delivery of RF-Energy.

• The safety and effectiveness of the use of this system in treating
children or pregnant women have not been established.

• This device should only be used by physicians thoroughly trained in
the techniques of transvenous intracardiac studies and/or
electrophysiology studies.

## Technical Specifications And Requirements {#technical-specifications-and-requirements .unnumbered}

## Cardima REVELATION^®^ Tx Dimensional Specifications {#cardima-revelation-tx-dimensional-specifications .unnumbered}

  ----------------------------- ------------------- -------------------------
  **Description**               **REVELATION**^®^   **NavAblator™**
                                **Tx**              

  Nominal Electrode Region      3.7 F, .048", 1.2   8 F, 0.105\", 2.7 mm
  Diameter                      mm                  

  Nominal Proximal Shaft        3.5 F, .045", 1.1   8 F, 0.105\", 2.7 mm
  Diameter                      mm                  

  Nominal Curve Reach           n/a                 30 mm (01-044001,
                                                    01-044007, 01-044013) 40
                                                    mm (01-044002, 01-044008,
                                                    01-044014)

  Working Length                150 cm              90 cm (01-044001,
                                                    01-044002)\
                                                    110 cm (01-044007,
                                                    01-044008)\
                                                    125 cm (01-044013,
                                                    01-044014)

  Tip Coil Length               1.0 cm              n/a

  Number of Electrodes          8                   4 (1 ablation, 3 mapping)

  Electrode Material            Platinum            Platinum

  Ablation Electrode Length     6 mm                4 mm

  Mapping Electrode Length      6mm                 1.5 mm

  Interelectrode Spacing        2 mm                2 mm

  Connectors: Quantity          1                   1

  Switchbox Requirements (not   Tx SELECT™          
  included)                     Switchbox           

  Connecting Cable (not         Tx Catheter Cable,  
  included)                     Tx ECG Cable        
  ----------------------------- ------------------- -------------------------

Tx RFG Cables for these commercially available RF Generators:

#   {#section-6 .unnumbered}

# Directions  {#directions .unnumbered}

**A. REVELATION**^®^ **Tx System Setup (see Figure 3)**

![](media/image5.png){width="6.090972222222222in"
height="3.8993055555555554in"}

###### Figure 3, REVELATION^®^ Tx Ablation System Set-up {#figure-3-revelation-tx-ablation-system-set-up .unnumbered}

1\. Attach the RF generator ground pad securely to the patient's skin
per manufacturers instructions.

> 2\. Connect the Cardima Tx SELECT^™^ Switchbox to the
> electrocardiograph, pacing stimulator, and RF generator using the
> appropriate connecting cables as specified in the Cardima Tx SELECT™
> Switchbox Instructions For Use.
>
> *NOTE: Adaptor cables are available for the Stockert 70, Medtronic
> Atakr and in Europe, the Osypka HAT 300 Smart generator. Please
> consult a Cardima representative.*
>
> a Select the appropriate NAVIPORT^®^ French size, curve reach and
> length.
>
> b\. Connect an RHV (Rotating Hemostatic Valve) adapter to the
> NAVIPORT^®^ hub.
>
> c\. Connect a pressurized, heparin/ saline flush bag to the RHV.
> Maintain a continuous drip.

d.  Introduce an appropriate size angiographic guidewire (e.g., .038")
    into the NAVIPORT^®^.

> 4\. Prepare the REVELATION^®^ Tx catheter for use.
>
> a\. Flush catheter with a heparin/saline solution while it is still in
> its protective dispensing coil.

b.  Remove catheter from dispensing coil and confirm electrode coil
    integrity.

> **B. Atrial Access**
>
> 1\. Place the NAVIPORT^®^/guidewire assembly through the introducer
> sheath and advance to the targeted area into the atrium under
> fluoroscopic guidance.

2.  Remove the guidewire from the NAVIPORT^®^.

> 3\. Place the introducer over distal tip of the REVELATION^®^ Tx to
> cover electrodes, then insert into RHV. Advance the REVELATION^®^ Tx
> through the introducer into the NAVIPORT^®^.
>
> 4\. Remove or pull back the introducer.
>
> 5\. Place the REVELATION^®^ Tx at the targeted area under fluoroscopic
> guidance and then connect it to the Cardima REVELATION^®^ Tx Catheter
> Cable.

6.  Hand off opposite end (male end) to be connected to switchbox.

> **C. Determination of Catheter/Tissue Contact**
>
> 1\. Observe the catheter on the fluoroscope to confirm correct
> positioning.
>
> 2\. Record bipolar electrical signals from the REVELATION^®^ Tx.
>
> In general, sharp electrograms with high frequency components and
> large relative amplitudes are suggestive of good contact.

D.  **RF Energy Delivery**

> 1\. Consult the appropriate RF generator operating manual before
> starting, and configure using the following settings:
>
> Control Mode: Constant Temperature
>
> Set Temperature: Initially 50° C
>
> Maximum Power: 35 W
>
> Differential Impedance
>
> Setting: Switch on if available and adjust to 20Ω.
>
> If not available, monitor impedance and stop RF energy delivery if
> impedance increases by more than 20Ω.
>
> Timer Set: 60 seconds
>
> These settings will allow power to be delivered up to a maximum of 35
> W during the course of the burn. RF energy will shutoff automatically
> after 60 seconds unless the impedance rises to a user-determined level
> in which case the shutoff will occur immediately.
>
> 2\. Determine which electrodes will receive RF energy based on the
> tissue contact assessment. Energy will be delivered to each electrode
> individually.
>
> 3\. Set the switchbox to correspond with the electrode receiving
> energy.
>
> 4\. If RF energy delivery automatically terminates (due to sudden rise
> in impedance) before 60 seconds, remove the REVELATION^®^ Tx at the
> completion of the burn line and inspect for coagulum on the
> electrodes. Loosely adherent coagulum may be carefully cleaned off the
> catheter electrodes with a saline-soaked 4 x 4 gauze. Do not apply
> force to the tip coil when wiping the electrodes. If strongly adherent
> char is not easily wiped off, or if any damage is observed, use
> another REVELATION^®^ Tx catheter.
>
> *NOTE: Following RF ablation electrogram amplitudes should decrease at
> least 25-50%.*
>
> *Note: To avoid phrenic nerve damage, prior to ablation, pace with a
> stimulator setting of 10 mA at 2 ms. Palpate the patient for a
> diaphragmatic stimulation. Do not apply RF energy at any location
> where diaphragmatic stimulation is detected in this manner.*
>
> 5\. Repeat steps D2-D4 above for the remaining electrodes with
> sufficient tissue contact.
>
> 6\. Repeat section C above to assess changes that have occurred as a
> result of the RF energy application. Repeat RF energy applications
> along a given trajectory as necessary. The set temperatures may be
> increased to a maximum of 60° C at the physician's discretion.
>
> 7\. Reposition the catheter in the next desired location and repeat
> sections C and D above until RF lesions are created in all desired
> trajectories.
>
> *NOTE: If frequent impedance rises during RF delivery are noted and/or
> an excessive amount of coagulum appears on the electrodes, it may be
> advisable to reduce the temperature setting or reposition the catheter
> prior to the next RF application.*
>
> ***NOTE: If bi-directional block is not achieved at the isthmus,
> the*** ***NavAblator™ may be used for this lesion.***
>
> **E.** **NavAblator™ Preparation**
>
> 3\. Prepare the NavAblator™ for use.
>
> a\. Remove the NavAblator™ from the sterile package under sterile
> conditions. As with all medical devices, always inspect prior to use
> to ensure no damage has occurred during shipping.
>
> b\. Prior to use, activate the deflection mechanism of the catheter by
> pulling the control knob. Then push the control knob distally to
> straighten the tip before inserting.
>
> c\. Place the NavAblator™ through the vascular introducer and advance
> to the atrium.
>
> 4\. Set the switchbox to **electrode position 1 only.**

5\. Follow the steps in B through D to create a line of block at the
isthmus. The duration of RF energy delivery may be increased from 20 to
120 seconds at the physician\'s discretion.

## Potential Complications {#potential-complications .unnumbered}

Risks to patients include all those risks currently associated with
electrophysiology diagnostic procedures and radiofrequency catheter
ablation procedures, such as:

• Bleeding

• Cardiac or vessel wall injury or perforation

• Cerebrovascular accident

• Conduction system abnormalities

• Death

• Hematoma at entry site

• Local or systemic infection

• Pericardial effusion

• Permanent atrioventricular block

• Phrenic nerve damage

• Pneumothorax

• Thromboembolic events

#  {#section-7 .unnumbered}

# Reports Of Adverse Events {#reports-of-adverse-events .unnumbered}

Major complication rate associated with this study were 3.4%. Minor
complications associated with this study occurred in 26% of the
subjects. There were no deaths associated with this study.

REPORTS OF CLINICAL STUDIES

Clinical studies were conducted of more than 80 subjects treated with
the investigational ablation system at approximately 20 investigational
sites. The Study Design was a prospective, non-randomized, single arm,
controlled study in which the patients serve as their own control. The
\"control\" consisted of a baseline model for each patient based upon
the number of symptomatic atrial fibrillation episodes documented by
that patient in a 30-day period (before treatment).

The study subjects were required by inclusion criteria to have
documented paroxysmal atrial fibrillation that did not respond to
antiarrhythmic drugs. If the patient was taking Amiodarone, he or she
need be unresponsive (refractory) to that one drug, otherwise, the
patient was required to be unresponsive to two antiarrhythmic drugs.

The objective of the study was to determine the safety and effectiveness
of the treatment system based upon a reduction in the number of
symptomatic AF episodes each patient had during the follow up period
compared to the number of episodes the patient had during the baseline
period. If the patient was found to have demonstrated a reduction of 50%
or more from the reported number of baseline episodes, he was deemed to
be a clinical success.

Eligible patients were treated and followed for 24 months, with
assessments at 1, 3, and 6, month intervals for the number of
symptomatic atrial fibrillation episodes they recorded and transmitted
and for the number and type of complications reported during the follow
up period.

Table 1, Mean Episode Reduction

  ------------- -------------- --------- ---------- -------- ---------- -------
  Number of     **Baseline**             **3                 **6        
  Episodes                               months**            months**   

                **freq**       **%**     **freq**   **%**    **freq**   **%**

  Total         111            100.0     93         100.0    81         100.0

  Mean, SD      9.9 ± 8.7                3.9 ^b^ ±           1.2 ^b^ ±  
                                         5.9                 2.0        
  ------------- -------------- --------- ---------- -------- ---------- -------

> ^a^ p\<0.0001, paired t-test

Table 2, Clinical Success

+----------------------------------------+--------------+-------------+
| **Criteria**                           | **3 Month**  | **6 Month** |
|                                        |              |             |
|                                        | **(n=93)     | **(n=81)    |
|                                        | freq/n (%)** | freq/n      |
|                                        |              | (%)**       |
+----------------------------------------+--------------+-------------+
| \# of subjects with Episode Reduction  | 76/93 (83.9) | 79/81       |
| compared to Baseline                   |              | (97.5)      |
+----------------------------------------+--------------+-------------+
| 50% Reduction ^a,^ ^c^                 | 58/93 (64.5) | 69/81       |
|                                        |              | (85.2)      |
+----------------------------------------+--------------+-------------+
| > 100% Reduction                       | > 33/93      | > 44/81     |
|                                        | > (35.5)     | > (54.3)    |
+----------------------------------------+--------------+-------------+
| \<50% Reduction ^c^                    | 33/93 (35.5  | 12/81 (14.8 |
|                                        | ^c^)         | ^c^)        |
+----------------------------------------+--------------+-------------+
| > No Reduction                         | > 15/93      | 2/81 (2.5)  |
|                                        | > (16.1)     |             |
+----------------------------------------+--------------+-------------+
|                                        |              |             |
+----------------------------------------+--------------+-------------+
|                                        |              |             |
+----------------------------------------+--------------+-------------+
|                                        |              |             |
+----------------------------------------+--------------+-------------+
| Mean % reduction ± SE                  | 53.1 ^b^ ±   | 82.9 ^b^ ±  |
|                                        | 6.6          | 3.0         |
+----------------------------------------+--------------+-------------+

> ^a^ 3-4 baseline episodes ^b^ p\<0.0001
>
> ^b^ Statistics do not include five subjects with disputed numbers of
> baseline episodes.
>
> ^c^ Includes those with "no reduction" as a subset of the \<50%
> reduction group. In the \>50% reduction group, those with 100%
> reduction are included.

![](media/image6.wmf)

#  {#section-8 .unnumbered}

#   {#section-9 .unnumbered}

# Customer Service Information {#customer-service-information .unnumbered}

If you have questions or comments regarding the use of this device,
please address them to:

CARDIMA, Inc. MedLink Europe B.V.

47266 Benicia St. Ravenswade 86-88

Fremont, CA 94538 USA 3439 LD Nieuwegein

\(800\) 354-0102 The Netherlands

\(510\) 354-0102 Voice + 31-30-2-870458

Fax (510) 354-0103 Fax + 31-30-2-800388

http://www.Cardima.com

##  {#section-10 .unnumbered}

## DISCLAIMER AND EXCLUSION OF OTHER WARRANTIES {#disclaimer-and-exclusion-of-other-warranties .unnumbered}

There are no warranties of any kind that extend beyond the description
of the warranties above. Cardima disclaims and excludes all warranties,
whether expressed or implied, or merchantability or fitness for a
particular use or purpose.

**LIMITED WARRANTIES**

Cardima^®^, Inc. warrants that this product is free from defects in
original workmanship and materials. Cardima warrants that sterile
products will remain sterile for a period of two years as labeled as
long as the original packaging remains intact. Cardima^®^'s products are
designed for single use only. Cardima^®^'s products are not designed for
reuse. If any Cardima^®^ product is proved to be defective in original
workmanship or original materials, Cardima^®^, in its absolute and sole
discretion, will replace or repair any such product, less charges for
transportation and labor costs incidental to inspection, removal or
restocking of product.

This limited warranty applies only to original factory delivered
products that have been used for their normal and intended uses.
Cardima^®^'s limited warranty shall NOT apply to Cardima^®^ products
which have been resterilized, repaired, altered, or modified in any way
and shall NOT apply to Cardima^®^ products which have been improperly
stored or improperly installed, operated or maintained contrary to
Cardima^®^'s instructions.

# LIMITATION OF LIABILITY FOR DAMAGES {#limitation-of-liability-for-damages .unnumbered}

In any claim or lawsuit for damages arising from alleged breach of
warranty, breach of contract, negligence, product liability or any other
legal or equitable theory, the buyer specifically agrees that Cardima^®^
shall not be liable for damages for loss of profits or revenues, loss of
use of the product, loss of facilities or services, any downtime costs,
or for claims of buyer's customers for any such damages. Cardima^®^'s
sole liability for damages shall be limited to the cost to buyer of the
specified goods sold by Cardima^®^ to buyer which give rise to the claim
for liability.

The buyer's use of the product shall be deemed acceptance of the terms
and conditions of these limited warrantees, exclusions, disclaimers and
limitations of liability for money damages.

**PATENT NUMBERS**

**xxxxxxxxxxxxxxxxxxxxxxxxxxx**