# Axcis™ PMR Delivery System {#axcis-pmr-delivery-system .unnumbered}

Part of the Eclipse PMR System

Catalog Number \_\_\_\_\_\_\_\_\_\_\_

**Information for Use**

> **Caution: Federal law restricts this device to sale by or on the
> order of a physician (or properly licensed practitioner). Federal law
> further restricts the use of this device to practitioners who have
> been trained in laser interventional cardiology including laser
> operation.**
>
> **Caution: Use of this device is restricted to patients who have
> signed a procedure-specific consent form to ensure that the risks
> associated with PMR have been fully explained and understood.**

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  ![](media/image1.wmf)0086             ![](media/image2.png)                     ![](media/image3.png)                    ![](media/image4.png)   

                              **Do not                          **Sterile-EtO**                           **Read                                   
                              reuse**                                                                     Instructions**                           
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> **1. DEVICE DESCRIPTION**
>
> The Eclipse PMR System is composed of the New Star Holmium:YAG laser,
> the ECG monitor and the Axcis PMR Delivery System. The laser
> radiation emitted from this system has a wavelength of approximately
> 2.1 microns, which is in the mid-infrared (invisible) range of the
> electromagnetic spectrum. Water is the target absorber for this laser
> wavelength. This laser emits 350 microsecond laser radiation pulses at
> a 35 millisecond pulse repetition interval. The energy output from the
> laser aperture is 2.7 Joules while the clinical level is 2 Joules per
> pulse. The pulses are synchronized with the cardiac cycle through the
> ECG monitor which provides a trigger signal to allow synchronization
> of the heartbeat with the delivery of laser energy. There is a visible
> laser beam used for calibration.
>
> The laser energy is delivered to the target tissue via an optical
> fiber. The Axcis PMR Delivery System is a single-use, coaxial assembly
> composed of two catheters---an outer Aligning Catheter and an inner
> Laser Catheter. The Axcis Aligning Catheter is available in several
> tip configurations (See Section 10, How Supplied). The System also
> includes an Introducer Tool, which is used to insert the Laser
> Catheter into the Aligning Catheter.
>
> **2. INDICATIONS FOR USE**
>
> The Eclipse PMR System is indicated for use in percutaneous myocardial
> revascularization (PMR) procedures to decrease angina and increase
> exercise tolerance in patients with chronic angina (Canadian
> Cardiovascular Society Angina Scale Class III or IV) which is
> refractory to medical treatment and secondary to objectively
> demonstrated coronary artery disease and with a region of the
> myocardium with reversible ischemia not amenable to direct coronary
> revascularization.

**3.** **CONTRAINDICATIONS**

> No contraindications known.

4.  **WARNINGS AND PRECAUTIONS**

-   The Axcis PMR Delivery System may only be used with an Eclipse PMR
    laser.

> **Explosion or fire hazard**

-   Do not operate the laser in the presence of flammable substances,
    including gases, anesthetics, cleaning agents, combustible
    materials, or other volatile substances. **Explosions or fire can
    result**.

-   Combustible or flammable materials (e.g. drapes, gowns or gauze) may
    be ignited by laser radiation unless they are kept wet or moistened.

-   Surround the procedure field with wet towels or wet gauze.

-   Modify all other flammable materials to make them fire-retardant
    (e.g. flame resistant drapes or gowns). Minimize oxygen exposure as
    oxygen increases the combustibility of materials exposed to laser
    radiation.

> **Laser radiation** The laser is classified as a Class IV laser
> product as defined in the Code of Federal Regulations (21 CFR
> 1040.10(b)\].

-   Avoid exposure to laser radiation at all times during the
    installation and operation of the laser as direct or reflected
    radiation may damage skin or eyes.

-   DO NOT LOOK DIRECTLY INTO THE LASER BEAM since permanent ocular
    damage may result.

-   Protect the patient's eyes by covering them with wet gauze or
    protective eyewear.

-   All catheterization laboratory personnel must wear protective
    eyewear with a minimum optical density of 3 at a wavelength of 2.1
    μm when the laser is in use.

> **Physician Training**

-   The Eclipse PMR System should only be used by properly trained
    cardiologists (see Section 11.3 Operator Training).

> **Handling and Sterilization of Axcis PMR Delivery System**

-   The Laser Catheter and Aligning Catheter are sterilized with EtO gas
    and are **for single-use only.** **Do not re-sterilize or reuse.**

-   The Introducer Tool is reusable and can be cleaned and
    re-sterilized. (see Section 11.2).

-   Inspect the sealed sterile package before opening. Product is
    sterile only in unopened, undamaged package. If the package is
    opened or damaged, or if the seal is broken, the contents may not be
    sterile and may cause infection in the patient.

-   Do not bend the fiberoptic at sharp angles. The Axcis Laser Catheter
    should not be bent beyond a bend radius of 7 mm.

> **Biohazard** After use, handle and dispose of the Laser and Aligning
> Catheters as appropriate for a biohazard.

**Precautions during PMR**

-   The wall thickness in the targeted region should be assessed prior
    to the PMR procedure using echocardiography. PMR should not be
    performed in areas of the myocardium that are:

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-   Less than 8 mm in wall thickness

-   Infarcted

-   In the region of the mitral valve or mitral valve apparatus

-   In the region of the papillary muscle

-   In the region of a left ventricular mural thrombus

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-   Subjects with pre-existing right bundle branch block are at higher
    risk of developing a complete heart block. Subjects with this
    pre-existing condition should not be treated in the septal area.
    Either a temporary pacemaker may be placed at the time of the PMR
    procedure or the proper equipment for the rapid insertion of a
    temporary pacemaker should be available.

-   PMR should only be performed under fluoroscopic observation and care
    must be taken not to duplicate channel locations. Firing the laser
    into a previously formed channel may cause perforation.

-   The Axcis PMR Delivery System consists of devices that are delicate
    and must be manipulated carefully.

-   The Axcis Aligning Catheter is stiffer than standard PTCA guiding
    catheters and can potentially place significant force on the heart
    wall. Care must be taken not to bend or wedge the optical fiber by
    pushing the lens too vigorously against the endocardium. The laser
    should never be fired under these conditions.

-   Do not fire the laser when the lens is retracted within the Aligning
    Catheter. Retract the lens before repositioning the Laser Catheter.

-   If the Axcis PMR Delivery system does not move freely, the catheters
    may be wedged within the left ventricle or the lens may be entrapped
    within trabeculae or the chordae tendinae. In this case, the Laser
    Catheter and lens should be withdrawn into the Aligning Catheter.
    The Aligning Catheter should then be withdrawn into a position that
    frees the device.

-   The Aligning Catheter may be used for manual contrast injections
    using a syringe only. The Aligning Catheter should not be used with
    a power injector. The Laser Catheter should not be used for contrast
    injection.

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-   If the patient experiences ventricular fibrillation during the
    procedure, discontinue the procedure and treat the arrhythmia as
    appropriate. A defibrillator should be readily available at all
    times during the procedure.

# 5. ADVERSE EFFECTS {#adverse-effects .unnumbered}

## 5.1 Observed Adverse Events {#observed-adverse-events .unnumbered}

> The "PACIFIC" randomized trial of PMR using the Eclipse PMR System
> plus medical management (PMR+MEDs) versus medical management alone
> (MEDs) enrolled 200 patients who were followed for a total of 185.6
> patient-years.
>
> There were no intra-procedural deaths in the study. Within 30 days of
> treatment, one PMR+MEDs patient died of cardiac causes. During 12
> months follow-up an additional 6 PMR+MEDs patients died (5 from
> cardiac causes and 1 from respiratory arrest) and 2 patients in the
> MEDs group died (both due to cardiac causes).
>
> A summary of all serious adverse events in the PACIFIC study is given
> in **Table 1**.

Table 1: Serious Adverse Events

Includes all adverse events, both related and unrelated to PMR, sorted
by system affected.

+-------------------------+---------+----------+-----------+---------+
|                         | **P     |          | **MEDs    |         |
|                         | MR+MEDs |          | (n=100)** |         |
|                         | (n      |          |           |         |
|                         | =100)** |          |           |         |
+-------------------------+---------+----------+-----------+---------+
| **Event^1\ ^**          | **P     | **Number | *         | *       |
|                         | atients | of       | *Patients | *Number |
|                         | with    | Events** | with      | of      |
|                         | Event** |          | Event**   | E       |
|                         |         |          |           | vents** |
+-------------------------+---------+----------+-----------+---------+
| ## All CV events        | 50      | 108      | 48        | 103     |
| combined {#all-cv-event |         |          |           |         |
| s-combined .unnumbered} |         |          |           |         |
+-------------------------+---------+----------+-----------+---------+
| Angina                  | 25      | 49       | 39        | 74      |
+-------------------------+---------+----------+-----------+---------+
| Arrhythmias^2^          | 11      | 12       | 4         | 6       |
+-------------------------+---------+----------+-----------+---------+
| Death (all causes)      | 7       | 7        | 2         | 2       |
+-------------------------+---------+----------+-----------+---------+
| Heart Failure           | 8       | 8        | 2         | 2       |
+-------------------------+---------+----------+-----------+---------+
| Injury to heart         | 3       | 3        | 0         | 0       |
| structure (perforation) |         |          |           |         |
+-------------------------+---------+----------+-----------+---------+
| Myocardial infarction   | 11      | 12       | 5         | 8       |
+-------------------------+---------+----------+-----------+---------+
| Other cardiovascular^3^ | 16      | 18       | 7         | 9       |
+-------------------------+---------+----------+-----------+---------+
| Thromboembolic disorder | 4       | 4        | 2         | 3       |
+-------------------------+---------+----------+-----------+---------+
| ## All DER Events C     | 1       | 1        | 2         | 3       |
| ombined {#all-der-event |         |          |           |         |
| s-combined .unnumbered} |         |          |           |         |
+-------------------------+---------+----------+-----------+---------+
| ## All GU Events        | 2       | 2        | 2         | 2       |
| Combined {#all-gu-event |         |          |           |         |
| s-combined .unnumbered} |         |          |           |         |
+-------------------------+---------+----------+-----------+---------+
| ## All GEN Events C     | 10      | 11       | 7         | 7       |
| ombined {#all-gen-event |         |          |           |         |
| s-combined .unnumbered} |         |          |           |         |
+-------------------------+---------+----------+-----------+---------+
| All GI Events Combined  | 8       | 12       | 3         | 4       |
+-------------------------+---------+----------+-----------+---------+
| All NEU Events Combined | 3       | 4        | 1         | 1       |
+-------------------------+---------+----------+-----------+---------+
| All PSY Events Combined | 2       | 2        | 1         | 2       |
+-------------------------+---------+----------+-----------+---------+
| All RES Events Combined | 7       | 10       | 3         | 4       |
+-------------------------+---------+----------+-----------+---------+
| All AE Combined         | 56      | 159      | 52        | 130     |
+-------------------------+---------+----------+-----------+---------+

^1^Abbreviations: CV = cardiovascular, DER = dermatologic, GEN =
general, GI = gastrointestinal, GU = genitourinary, HEM = hematologic,
LAB = laboratory, MET = metabolic, MUS = musculoskeletal, NEU =
neurologic, PSY = psychiatric, RES = respiratory, AE = adverse events.

^2^Arrhythmias (number of patients with each in treatment/control
groups) were: arrhythmia (0/2), ventricular arrhythmia (1/0), AV block
complete (1/0), bradycardia (4/1), atrial fibrillation (2/0), atrial
flutter (2/0), heart block (1/0), tachycardia (0/1).

^3^Other cardiovascular events (number of patients with each in
treatment/control groups) were: heart arrest (4/0), syncope (2/2),
vascular disease peripheral (3/2), amblyopia (0/1), vascular anomaly
(1/0), cellulitis (1/0), creatine PK increase (1/0), pericardial
effusion (1/0), embolism (1/0), hypotension (1/0), artery occlusion
(0/1), carotid occlusion (0/1), coronary stenosis (1/0), ulcer (1/0).

### 5.2 Potential Adverse Events {#potential-adverse-events .unnumbered}

> Possible adverse effects include but are not limited to the following:

-   death

-   myocardial perforation which can lead to tamponade

-   abnormalities of cardiac function (myocardial infarction, left
    ventricular dysfunction, heart failure, cardiogenic shock,
    arrhythmias )

-   thromboembolic disorders and stroke

-   respiratory failure

-   arterial dissection

-   infection

-   inadvertent injury to structures of the heart

-   inadvertent injury to structures outside of the heart

-   fragmented catheters and lens tips

-   vascular damage

# 6. CLINICAL STUDY {#clinical-study .unnumbered}

> **Purpose:** The purpose of this study was to compare PMR and medical
> management (PMR + MEDs) to medical management alone (MEDs). **Primary
> outcome measures** were angina classification and exercise tolerance;
> quality of life was a secondary outcome measure and safety measures
> were mortality and adverse events.
>
> **Design and Patients:** This multi-center, prospective, randomized
> controlled trial was conducted at 11 U.S. centers with 200 patients
> studied between November 1997 and August 1999; 100 randomized to PMR
> and 100 randomized to MEDs. There were 17 withdrawals and 9 deaths.
> The remaining 174 patients reached one year follow-up. Baseline
> characteristics and cardiac risk factors were similar between the two
> groups.
>
> **Methods:** PMR was performed using standard percutaneous techniques
> via the femoral artery through a 9F or 10F introducer sheath. The
> Axcis PMR Delivery System catheters were advanced into the left
> ventricle. Channels were created from the endocardium approximately 5
> mm into the myocardium. All channel placement was guided by
> fluoroscopy.
>
> **Results: Table 2** lists the principal safety and effectiveness
> results. There were statistically significant differences in angina
> improvement and exercise tolerance (defined as total duration of
> exercise testing).

Table 2: Principal Safety and Effectiveness Results

+-------------------------------+-------------+--------------+--------+
| All patients in the           | PMR+MEDs    | MEDs (n=100) | P      |
| Randomized Trial (n=200)      | (n=100)     |              | -value |
+-------------------------------+-------------+--------------+--------+
| Angina Improvement            | 42.0%       | 8.0% (n=8)   | \      |
|                               | (n=42)      |              | <0.001 |
| Success                       |             | 92.0% (n=92) |        |
|                               | 58.0%       |              |        |
| Failure                       | (n=58)      |              |        |
+-------------------------------+-------------+--------------+--------+
| 12-Month Angina Distribution  | 0.0% (n=0)  | 1.0% (n=1)   | 0.001  |
|                               |             |              |        |
| None                          | 29.0%       | 4.0% (n=4)   |        |
|                               | (n=29)      |              |        |
| Class I                       |             | 11.0% (n=11) |        |
|                               | 35.0%       |              |        |
| Class II                      | (n=35)      | 44.0% (n=44) |        |
|                               |             |              |        |
| Class III                     | 14.0%       | 38.0% (n=38) |        |
|                               | (n=14)      |              |        |
| Class IV                      |             |              |        |
|                               | 15.0%       |              |        |
|                               | (n=15)      |              |        |
+-------------------------------+-------------+--------------+--------+
| Mortality                     | 1.0% (1)    | 0% (0)       | 0.170  |
|                               |             |              |        |
| \<30 days                     | 6.0% (6)    | 2% (2)       |        |
|                               |             |              |        |
| [\>]{.underline}30 days       |             |              |        |
+-------------------------------+-------------+--------------+--------+
| Exercise Tolerance            | 50.8 (n=99) | -6.4 (n=97)  | 0.014  |
| Improvement                   |             |              |        |
+-------------------------------+-------------+--------------+--------+
| Quality of Life Improvement   | 12.3 (n=95) | 0.4 (n=95)   | \      |
|                               |             |              | <0.001 |
| Physical Limitation Scale     | 26.0 (n=96) | 4.2 (n=96)   |        |
|                               |             |              | \      |
| Anginal Stability Scale       | 19.3 (n=95) | 7.1 (n=97)   | <0.001 |
|                               |             |              |        |
| Anginal Frequency Scale       | 9.4 (n=96)  | 1.7 (n=97)   | \      |
|                               |             |              | <0.003 |
| Treatment Satisfaction Score  | 28.5 (n=96) | 9.1 (n=97)   |        |
|                               |             |              | \      |
| Disease Perception Score      |             |              | <0.001 |
|                               |             |              |        |
|                               |             |              | \      |
|                               |             |              | <0.001 |
+-------------------------------+-------------+--------------+--------+

[Angina Improvement:]{.underline} Success was defined as improvement of
2 or more CCSAS classes from baseline to 12 months.

[12-Month Angina Distribution]{.underline}: Distribution of angina at 12
months by CCSAS class as assessed by the Clinical Investigator at each
site.

[Mortality]{.underline}: Proportionate analysis p = 0.170 by 2-Tail
Fisher's Exact Test and 0.089 by Kaplan Meier Analysis, Log Rank Test.

[Exercise Tolerance Improvement]{.underline}: Improvement in exercise
duration in seconds from baseline to 12 months.

[Quality of Life Improvement]{.underline}: Seattle Angina Questionnaire
analysis scores improvement from baseline to 12 months. Higher scores
indicate higher quality of life.

7.  **PATIENT SELECTION AND TREATMENT**

#  Specific Patient Populations  {#specific-patient-populations .unnumbered}

The safety and effectiveness of the Eclipse PMR System has not been
established for the following specific populations:

-   patients under the age of 18;

-   patients who are pregnant or undergoing labor and delivery or are
    nursing mothers;

-   patients suffering from active hepatic disease, renal failure,
    cancer or major infection;

-   patients with a left ventricular ejection fraction less than 30%;

-   patients with CCSAS class II or better angina;

-   patients with myocardial ischemia limited to the right ventricular
    wall.

8.  **PATIENT COUNSELING INFORMATION**

> This device is restricted to use in patients who sign a
> procedure-specific informed consent to ensure that the risks
> associated with PMR have been fully explained to, and understood by,
> the patient.

Patients should be advised that any reduction of angina may occur
gradually, that they should continue on their anti-anginal medications,
and that the need for these medications will be re-evaluated at
subsequent visits.

Patients should be advised of the risks of the procedure including the
possibility of:

-   recurrence of angina;

-   progression of myocardial ischemia;

-   worsening heart failure;

-   cardiac arrhythmia;

-   death

    **9. CONFORMANCE TO STANDARDS**

    The Eclipse PMR System laser conforms with the requirements of the
    following domestic and international standards:

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-   IEC601-1:1988 Medical Electrical Equipment, General Requirements for
    Safety

-   IEC60601-1-2:1993 Medical Electrical Equipment, General Requirements
    for Safety, Collateral: Electromagnetic

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-   IEC601-2-22: 1992 Medical Electrical Equipment, Particular
    Requirements for the Safety of Diagnostic and Therapeutic Laser
    Equipment.

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-   21CFR Part 1040.10 Laser Product Performance Standard

    The ECG monitor meets the requirements of:

-   EN55011, Group I, Class A 1991 Conducted Emissions and Radiated
    Emissions

-   EN 61000-4-2, 1995-01 Electrostatic Discharge Immunity

-   EN 61000-4-3 1995-02 Radiated Electromagnetic Immunity

-   EN 6100-4-4 1995-01 Electrical Fast Transient/Burst Immunity

-   EN 50141 1994 Conducted Disturbance Induced by RF Fields

# 10. HOW SUPPLIED {#how-supplied .unnumbered}

# [Packaging]{.smallcaps}

> The Eclipse PMR System consists of the New Star laser, the ECG
> monitor, the disposable Axcis PMR Delivery System (Axcis Laser
> Catheter, Axcis Aligning Catheter) and the Introducer Tool.

-   The laser and ECG monitor are initially installed in the hospital by
    Eclipse personnel.

-   The single-use delivery system is supplied sterile and
    non-pyrogenic. Sterility may be compromised if the package is opened
    or damaged. Do not re-sterilize the Axcis Laser or Aligning
    Catheters.

-   The Introducer Tool may be re-used if desired and must be cleaned
    and sterilized according to the procedures outlined in this
    document. (see Section 11.2)

    2.  Storage

> All fiberoptic delivery system catheters should be stored under
> conditions that protect against extremes of temperature and humidity.
> Products should be stored in a clean, dry environment, protected from
> water. Do not stack other objects on packaging to avoid crushing.
> Proper stock rotation should be practiced. Store in a cool, dry area.
> Do not expose to organic solvents, ionizing radiation or ultraviolet
> light.

3.  Axcis PMR Delivery System

> Axcis Aligning Catheter: Ultra-1, Ultra-1 Long, Ultra-2, Ultra-3 and
> Open-2 configurations to reach various cardiac anatomies
>
> Axcis Laser Catheter: fiberoptic which delivers laser energy
>
> Introducer Tool tool used to insert the Laser Catheter into the
> Aligning Catheter
>
> SMA Cleaning Kit lint-free swabs and pre-moistened pads to clean the
> laser fiberoptic receptacle

10.4 Materials Required for Use (Not Provided)

-   9F introducer sheath for femoral artery access

-   5F or 6F introducer sheath for contralateral femoral artery access
    (optional)

-   7F or 8F introducer sheath for femoral vein access

-   appropriately shaped angiographic catheter(s)

-   0.035-inch. or 0.038-inch guide wire

-   6F angiographic pigtail catheter, 125 cm long

-   right-heart catheter for measurement of pulmonary artery pressures
    (optional)

-   pressure transducers (2)

-   pressure bags with infusion line sets including 3-way stopcocks (2)

-   Heparinized saline, 1,000 U/liter or per standard practice, 500 ml
    bags (2)

-   2D echo

-   pericardiocentesis set

-   plastic transparency film for marking of channel locations on fluoro
    monitors

> **11. CLINICIAN USE INFORMATION**

1.  **Patient Informed Consent**

In addition to the standard consent form, Eclipse requires a
procedure-specific consent form to be signed by each patient to ensure
that the risks associated with PMR have been fully explained to the
patient.

2.  **Device Operating Instruction**

> **[Inspection Prior to Use]{.smallcaps}**
>
> ![](media/image5.png){width="0.24305555555555555in"
> height="0.2125in"}Prior to the procedure, carefully inspect all
> equipment to ensure that no component of the Axcis PMR Delivery System
> has been fractured or damaged. If there is any damage to a component
> or its packaging, the component should not be used. Any damaged
> component should be returned to Eclipse Surgical Technologies, Inc.
>
> Note the location of the stainless steel Introducer Tool within the
> Laser Catheter pouch. Care should be taken to preserve sterility
> during removal of the Introducer Tool from the pouch.
>
> **[Pre Procedure Preparation]{.smallcaps}**
>
> 1\. Ensure that everyone in the room is wearing laser safety goggles.
>
> 2\. Attach the power cord to an appropriate power outlet.
>
> 3\. Clean the laser fiberoptic receptacle. Carefully clean the inner
> surface of the fiberoptic receptacle using a lint-free cleaning swab.
> Upon removal of the cleaning swab from the laser, inspect the swab for
> dust or debris. Repeat this procedure using new cleaning swabs until
> the swab comes away from the laser free of visible signs of dust or
> debris. To avoid possible damage to the laser optics, do not insert
> the cleaning swab more than 2 cm into the fiberoptic receptacle.
>
> Carefully clean the outer surface of the fiber receptacle using a
> pre-moistened cleaning pad. Inspect the cleaning pad for dust or
> debris. Repeat this procedure using new cleaning pads until the pad
> comes away from the laser clean and free of visible signs of dust or
> debris.
>
> 4\. Place electrodes on the patient's right arm, left arm, and left
> leg. Attach the leads to the electrodes on the patient and connect the
> cable to the front of the ECG monitor. Attach the ECG monitor to the
> laser. See the Eclipse PMR Holmium Laser System User Manual for
> instructions.
>
> 5\. Turn on the ECG monitor and the laser. Test the function of the
> laser prior to patient preparation. See the Eclipse PMR Holmium Laser
> System User Manual for instructions.
>
> 6\. At this point, femoral and venous (optional) access should be
> secured. Use 9F or 10 F for the Axcis PMR system, 5F or 6F on the
> contralateral femoral artery \[optional\] and 7F or 8F for the femoral
> vein(optional).

7.  Introduce a diagnostic coronary catheter through the smaller femoral
    sheath. Place a 6F pigtail and guidewire.

8.  Introduce the Aligning Catheter through the appropriate femoral
    sheath. Introduce the Aligning Catheter over a 6F pigtail catheter
    and a guidewire into the left ventricle.

9.  For fluoroscopy, isocenter should be determined prior to proceeding
    to the next step and should be maintained throughout the procedure.

10. Acquire orthogonal fluoro projections optimized for the targeted
    region; record coronary and ventricular angiograms.

11. The Aligning Catheter should be advanced over the pigtail into the
    apical region in preparation for the introduction of the Laser
    Catheter.

12. **Once working projections have been established at this point, the
    TABLE SHOULD NOT BE MOVED.** Moving the table will result in an
    inability to accurately localize channels relative to the cardiac
    anatomy.

> **[Preparation of the Laser Catheter:]{.smallcaps}**
>
> **Note**: The following steps are to be performed by both a
> scrubbed-in assistant, for catheter preparation, and a non-scrubbed-in
> laser operator.
>
> 13\. Using standard sterile technique, remove the Laser Catheter from
> the pouch.
>
> 14\. Remove the Introducer Tool and place it in the sterile field for
> later use. Remove the Laser Catheter from the package.
>
> 15\. Transfer the proximal SMA laser connector to the non-sterile
> person who will operate the laser. The laser operator should then
> remove the protective cap.
>
> 16\. Insert the connector into the laser. It is extremely important
> that this step be performed slowly and carefully. The following steps
> should be taken to insure that the Laser Catheter is successfully
> attached to the laser:

-   The cylindrical portion of the connector must be inserted very
    slowly and carefully into the laser receptacle. The face of the
    connector, which contains the optical fiber, must not be brought
    into contact with the laser receptacle. The connector must then be
    slowly inserted using gentle force that is directed straight into
    the receptacle. No binding or drag should occur as the connector is
    inserted. Binding or drag indicates that the connector is not being
    inserted straight into the receptacle.

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-   Once fully seated, the nut should be fully tightened onto the
    receptacle.

> **[CLINICAL USE]{.smallcaps}**

17. Test the Axcis Laser Catheter as follows:

-   Partially fill a small basin with sterile water.

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-   While wearing laser safety glasses, place laser in READY mode.

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-   Place the distal end of the optical fiber into the basin, such that
    the lens is submerged in water and 1-2 cm from the side or bottom of
    the basin. Depress the laser footswitch. Energy from the fiber
    should cause the water to vaporize with a snapping sound; there
    should be no error code displayed on the laser. If a distinct
    snapping sound is not heard when the laser fires, or if white
    flashing at the lens is noted when the laser fires, do not use the
    catheter for the procedure. Prior to attaching a new catheter to the
    laser, clean the laser fiber receptacle per the instructions in step
    3 above.

> **[Attachment and Adjustment of Heparinized Saline Drip
> Lines:]{.smallcaps}**

18. Fully advance the fiber so that 7-8 cm are extended.

19. Flush both the proximal and distal sideports with saline and attach
    drip lines with stopcocks closed. Drip lines should be attached to
    two individual pressure bags pressurized to 300 mm Hg and filled
    with heparinized saline.

20. Open the stopcocks and adjust for appropriate drip rate. Close the
    stopcocks.

21. Place the Laser Catheter onto the sterile field. It is now prepared
    for introduction through the Aligning Catheter.

22. Place a piece of plastic transparency film over the fluoro screen
    and trace the major coronary arteries and other anatomical
    landmarks. Record the angulation and tilt of the projection on the
    transparency. Do this for both projections that will be used during
    channel creation. From this point forward, these projections must be
    used in order to maintain the ability to accurately localize
    channels.

**[Introducing the Laser Catheter:]{.smallcaps}**

> 23\. **Visually inspect the Introducer to ensure that the Introducer
> is undamaged and that the slot width is uniform**. Insert the fiber
> into the slot of the Introducer.
>
> 24\. Holding the fiber and catheter tip, slowly retract the lens into
> the Introducer. Verify that the petals fold into the Introducer
> without catching on the edge. **Do not force the lens into the
> Introducer. Discard any Introducer that presents excessive resistance
> to the insertion of the lens.**

25. Open the stopcocks on both of the heparinized saline drip lines.

26. Insert the Introducer into the hub of the Aligning Catheter. Insert
    the Laser Catheter into the Aligning Catheter.

27. When the lens is fully within the Aligning Catheter, remove the
    Introducer. Maintain sterility of the Introducer since it may be
    needed again.

28. Once the shaped tip of the Laser Catheter is 5-10 cm into the
    Aligning Catheter, slide the distal sidearm forward and attach to
    the Aligning Catheter. Exercise care to not draw the Aligning
    Catheter out of the ventricle.

29. Fully retract the fiber and advance the Laser Catheter until the
    radiopaque lens marker is seen in the most distal segment of the
    Aligning Catheter. At that point, the Laser Catheter should not be
    advanced further but should be held in position as the Aligning
    Catheter is retracted in an "unsheathing" motion.

30. At this point the trigger delay should be adjusted to end-systole
    according to the instructions in the laser User Manual. The trigger
    point is indicated by the bright spot on the ECG tracing. The
    trigger point should be monitored periodically throughout the
    procedure and adjusted as required to maintain an end-systolic
    triggering point.

**[Manipulating the Axcis PMR Delivery System]{.smallcaps}**

> 31\. Once the catheters are in the left ventricle, the user can
> manipulate them by any of the following adjustments to target the
> various regions of the heart:

(a) advancement/retraction of the entire system *en bloc*

(b) rotation of the Aligning Catheter

(c) advancement/retraction of the Laser Catheter with the Aligning
    Catheter held stationary

(d) rotation of the Laser Catheter with the Aligning Catheter held
    stationary

(e) advancement/retraction of the optical fiber/lens with the Laser and
    Aligning Catheters held stationary

> DO NOT TORQUE THE LASER CATHETER WHEN THE SHAPED TIP IS WITHIN THE
> ALIGNING CATHETER
>
> DO NOT EXTEND OR RETRACT THE LENS WHEN THE LASER CATHETER TIP IS
> WITHIN THE ALIGNING CATHETER
>
> 32\. Using these adjustments, various catheter configurations are
> possible, including the following:
>
> \(a\) "C" configuration, in which the curves of both catheters lie in
> the same plane and point in the same direction
>
> \(b\) "S" configuration, in which the curves of both catheters lie in
> the same plane but point in opposite directions
>
> \(c\) "MP" (multiplane) configuration, in which the curves of both
> catheters lie in orthogonal planes
>
> It may be useful to orient the tip of the Aligning Catheter toward the
> apex and then target specific regions by rotating and/or
> advancing/retracting the Laser Catheter with the Aligning Catheter
> held in a stable position. Rotational control of the Laser Catheter is
> accomplished by rotation of the tapered nose cone located on the
> proximal controller assembly.

33. Configurations that permit only slight extension of the lens from
    the Laser Catheter and the Laser Catheter from the Aligning Catheter
    should be avoided, since they will cause potentially dangerous
    loading of the lens against the endocardium.

34. Using these adjustments and configurations, position the Axcis PMR
    System so that the lens is aimed at the targeted region. Then
    confirm the position of the device by fluoroscopy, using projections
    that provide orthogonal views.

35. Once the appropriate position has been confirmed, the lens should be
    moved toward the endocardium by slowly advancing the fiber handle
    located on the proximal controller assembly.

36. Contact with the myocardial wall is usually indicated by
    fluoroscopic visualization of the catheter "backing away" from the
    wall, as well as by a change in the motion of the radiopaque marker
    located on the distal-mounted lens: it will change from a slight
    reciprocating movement to a noticeable beating motion when it comes
    in contact with the beating heart. Initial contact is also commonly
    indicated by the occurrence of premature ventricular contractions
    (extrasystoles). IT IS IMPORTANT THAT THE FIBER NOT BE SQUEEZED OR
    WEDGED AGAINST THE ENDOCARDIUM, AS EVIDENCED BY SEVERE FLEXING.

Creating Channels

  -----------------------------------------------------------------------
  **NOTE: The laser should not be fired with the lens positioned in an
  infarct region. The laser should not be fired with the lens positioned
  in the region of the mitral valve or the mitral valve apparatus.**

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

37. Place the laser in READY mode by pressing the READY button on the
    laser control panel.

38. With the laser in READY mode, depress the foot switch. The laser
    will fire a burst of pulses equal to the pulse preset setting on the
    laser control panel.

> Note: Channels may be formed using either one or two bursts of laser
> energy, each burst typically consists of two pulses. If a second burst
> is desired, proceed with the following step; otherwise omit the
> following step.

39. Following very slight additional advancement of the optical fiber
    (approximately 1 mm), fire a second burst by depressing the foot
    switch. Two bursts of two pulses per burst are customarily fired for
    each channel attempt in a region with wall thickness of 8 mm or
    greater.

40. Mark the channel location on the transparencies in both orthogonal
    views.

41. After marking the channel location, retract the fiber to its
    fully-retracted position and reposition for the next channel.
    Channels should be spaced approximately 1 cm apart.

42. Repeat this sequence for the desired number of channels.

43. With the optical fiber fully retracted, remove the Laser Catheter by
    withdrawing it through the Aligning Catheter.

44. Ventriculography should be performed in at least two optimized
    planes.

45. Remove the Aligning Catheter by withdrawing it through the femoral
    sheath.

46. Removal of the access sheaths and subsequent achievement of
    hemostasis should be performed according to standard practice.

47. Reuse of the Introducer Tool:

> **Pre-Cleaning (Introducer Tool only)**
>
> The Introducer Tool should be rinsed thoroughly using lukewarm water
> (below 43° C / 110° F) immediately following use.
>
> **Cleaning (Introducer Tool only)**
>
> The Introducer Tool should be cleaned following each procedure using a
> low-sudsing, protein-dissolving detergent or a combination of an
> enzymatic cleaner followed by a manual detergent. Follow the
> manufacturer's instructions regarding concentration, temperature,
> contact time and reuse. Clean using a soft-bristle brush. Do not soak
> in hot water, alcohol, disinfectants or anti­septics to avoid
> coagulation of blood or other body fluids. Do not use steel wool, wire
> brushes or abrasive detergents.
>
> Rinse thoroughly with water to remove all traces of debris or
> cleansing agents. **Inspect the Introducer Tool to ensure that it is
> undamaged and that the slot width is uniform.**
>
> **STERILIZATION (Introducer Tool only)**
>
> The Introducer Tool should be sterilized in a gravity-displacement
> steam-sterilization cycle of 15 minutes at a minimum of 132° C (270°
> F) or a pre-vacuum steam-sterilization cycle of 4 minutes at a minimum
> of 132° C (270° F).

**11.3 Operator Training**

> Federal law restricts the use of this device to practitioners who have
> been trained in laser cardiology intervention techniques including
> laser operation. Operator training for use of the Eclipse PMR System
> must include training in the use of the laser and the fiberoptic
> delivery system, as well as appropriate clinical training.
>
> **Laser Training:**
>
> The American National Standards Institute offers the following
> Standard of Practice for the Use of Lasers in Medicine and Surgery:
>
> ANSI Z136.3 "American National Standard for Safe Use of Lasers in
> Health Care Facilities", 1996.
>
> **Clinical Training:**
>
> Use of the Eclipse PMR System should only be undertaken by personnel
> who have met the standards of the Eclipse continuing education
> training program, which includes didactic and hands-on-training
> covering:

-   Patient selection

-   Percutaneous myocardial revascularization technique

-   Patient management.

> Further information about training can be obtained form an Eclipse
> Surgical Technologies, Inc. representative at 800-238-2205.

# 12. Patient's Manual {#patients-manual .unnumbered}

> The brochure "Information for Patients considering Percutaneous
> Myocardial Revascularization (PMR)" provides general information to
> the potential patient regarding the risks and benefits associated with
> PMR treatment.

# 13. Product Information Disclosure {#product-information-disclosure .unnumbered}

> Eclipse Surgical Technologies, Inc. ("Eclipse") has exercised
> reasonable care in the manufacture of this device. Eclipse excludes
> all warranties, whether express or implied by operation of law or
> otherwise, including but not limited to any implied warranties of
> merchantability or fitness, since handling, storage, and sterilization
> of this device by the user, as well as factors relating to the
> patient, diagnosis, treatment, and other matters beyond the direct
> control of Eclipse affect this device and the results obtained with
> its use.
>
> Eclipse shall not be liable for any incidental, or consequential loss,
> damage, or expense directly or indirectly arising from the use of this
> device. Eclipse neither assumes, nor authorizes any other person to
> assume for it, any other or additional liability or responsibility in
> connection with this device.

+-----------------------------------+-----------------------------------+
| The Product is manufactured by:   | European Legal Representative:    |
|                                   |                                   |
| Eclipse Surgical Technologies,    | Medical Device Consultants Intl,  |
| Inc.                              | Ltd.                              |
|                                   |                                   |
| 1049 Kiel Court                   | Independent House                 |
|                                   |                                   |
| Sunnyvale, CA 94089               | Imberhorne Lane                   |
|                                   |                                   |
| USA                               | East Grinstead RH 19 1XT          |
|                                   |                                   |
| +(800) 238-2205                   | United Kingdom                    |
|                                   |                                   |
| FAX (408) 548-2168                | +44 1293 429608                   |
|                                   |                                   |
|                                   | FAX 44 1293 519121                |
+-----------------------------------+-----------------------------------+

Made in U.S.A.

The Axcis PMR System, Eclipse Surgical Technologies PMR Laser are
covered under one or more of the following U.S. patents: 5,093,877;
5,380,316; 5,389,096, 5,785,702; 5,885,272; 5,931,834; 5,951,567.
Eclipse and the Eclipse logo are registered trademarks and Axcis is a
trademark of Eclipse Surgical Technologies Corporation in the United
States. U.S. and international patents pending.

Copyright 1999, Eclipse Surgical Technologies Corporation. All rights
reserved.