Eclipse PMR Holmium Laser System

**Information for Use**

**Eclipse Surgical Technologies, Inc.**

1049 Kiel Court

Sunnyvale, CA 94089

Main (408) 548-2100

FAX (408) 548-2168

Customer Service (800) 238-2205

Page

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.

# 1. DEVICE DESCRIPTION

The Eclipse PMR System is composed of the New Star Holmium: YAG Laser,
the ECG monitor and delivery system catheters. 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 has been designed for this
> purpose and consists of the Axcis Laser Catheter and the Axcis
> Aligning Catheter. The Laser Catheter contains a single solid core
> optical fiber of approximately 365 m diameter terminated with a quartz
> lens and contained within a braided PEBAX shaft. The Aligning Catheter
> is an approximately 9F braid-reinforced catheter which comes in 5
> different tip configurations to facilitate access to various shaped
> cardiac anatomies.(see Section 10.3).

# 2. INDICATIONS FOR USAGE

> 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 Class III or IV) which is refractory to medical
> treatment and secondary to objectively demonstrated coronary artery
> atherosclerosis and with a region of the myocardium with reversible
> ischemia not amenable to direct coronary revascularization.

# 3. CONTRAINDICATIONS

No contraindications known.

# WARNINGS and PRECAUTIONS

> See [warnings and precautions]{.smallcaps} in the final draft labeling
> (Information for Use).

-   The Axcis PMR System may only be used with the New Star Laser.

-   

-   Explosions 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.

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

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

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-   Modify all other flammable materials to make them fire-retardant
    (for example flame resistant drapes and 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 (CRF 21
    Section 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 Ho:YAG LASER BEAM as it can cause
    permanent ocular damage.

-   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 m
    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** **the Axcis** **PMR** **Delivery
    System**

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

-   Inspect sealed sterile package before opening. Product is sterile
    only in unopened, undamaged package. If package is opened or
    damaged, or if seal is broken, 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.

-   The Introducer Tool is reusable and can be cleaned and
    re-sterilized.

#### - Pre-cleaning (Introducer Tool only): Rinse the tool thoroughly using lukewarm water (below 43C/110F). {#pre-cleaning-introducer-tool-only-rinse-the-tool-thoroughly-using-lukewarm-water-below-43c110f. .PMA-.25-Caption .unnumbered}

#### Cleaning (Introducer Tool only): Clean using a low-sudsing, protein-dissolving detergent or a combination of an enzymatic cleaner followed by a manual detergent. Follow 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.  {#cleaning-introducer-tool-only-clean-using-a-low-sudsing-protein-dissolving-detergent-or-a-combination-of-an-enzymatic-cleaner-followed-by-a-manual-detergent.-follow-manufacturers-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. .PMA-.25-Caption}

#### 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.** {#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. .PMA-.25-Caption}

#### Sterilization (Introducer Tool only): The Introducer Tool should be sterilized in a gravity-displacement steam-sterilization cycle of 15 minutes at a minimum of 132C (270F) or a pre-vacuum steam-sterilization cycle of 4 minutes at a minimum of 132C (270F). {#sterilization-introducer-tool-only-the-introducer-tool-should-be-sterilized-in-a-gravity-displacement-steam-sterilization-cycle-of-15-minutes-at-a-minimum-of-132c-270f-or-a-pre-vacuum-steam-sterilization-cycle-of-4-minutes-at-a-minimum-of-132c-270f. .PMA-.25-Caption}

####  {#section .PMA-.25-Caption .unnumbered}

#### **Biohazard** \-- After use, handle and dispose of the Laser and Aligning Catheters as appropriate for a biohazard. {#biohazard----after-use-handle-and-dispose-of-the-laser-and-aligning-catheters-as-appropriate-for-a-biohazard. .PMA-.25-Caption}

-   **Precautions During** **PMR**

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-   The wall thickness in the targeted region should be assessed by
    echocardiography prior to the PMR procedure. 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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-   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 PMR Delivery System 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 myocardium.

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

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-   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 cordae 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 proximal end of the Laser Catheter should not be rotated more
    than two revolutions in instances in which the distal end is not
    rotating. Further rotation may result in kinking or other mechanical
    failure of the catheter.

-   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.

-   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 EVENTS {#adverse-events .unnumbered}

## 5.1 Observed Adverse Events

> The randomized trial of PMR, the PACIFIC Study, used the Eclipse PMR
> System to compare treatment plus maximal anti-anginal medications
> (PMR+MEDs) with medical management alone (MEDs). The study enrolled
> 200 patients who were followed for an average of 11.1 months.
>
> 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 subjects in the
> MEDs group died (both due to cardiac causes).
>
> Serious Averse Events which occurred in the study are summarized 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

Adverse events potentially associated with the use of PMR, but not
observed in the study, include (in alphabetical order):

  ----------------------------------- -----------------------------------
  Allergic reaction to contrast agent Fragmented catheters and lens tip

  Arterial Dissection                 Left ventricular dysfunction

  Bleeding                            Renal insufficiency

  Cardiogenic shock                   Vascular damage

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

# 6. CLINICAL STUDIES {#clinical-studies .unnumbered}

> **Purpose:** The purpose of the PACIFIC Study was to compare PMR plus
> medication (PMR+MEDs) with medication alone (MEDs). Primary outcome
> measures were angina improvement and improvement in exercise tolerance
> testing. The secondary outcome measure was improvement in quality of
> life.
>
> **Design and Patients:** This multi-center, prospective, randomized
> controlled trial was conducted at 11 U.S. centers. The study was
> conducted between November 1997 and August 1999 with 200 patients
> enrolled, 100 randomized to PMR+MEDs and 100 randomized to MEDs. There
> were 17 withdrawals from the study and 9 deaths. All of 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 a percutaneous access route
> typical of other interventional cardiac procedures. The Laser Catheter
> containing the fiberoptic was introduced through the Aligning Catheter
> and used to apply laser energy to the endocardial surface of the left
> ventricle. As the fiber was advanced, pulsed laser energy was
> delivered to the myocardium until the optical fiber tip penetrated to
> a depth of 8 mm or less. PMR channels were placed approximately 1 cm
> apart using fluoroscopic visualization for catheter placement. The
> laser was synchronized to fire at the electrocardiographic R-wave,
> when the left ventricle was at maximum contractile width.
>
> **Results:** The number of PMR channels created during the procedure
> ranged from 8 to 35 (mean 16.1), using an energy of 2 Joules per
> pulse. **Table 2** summarizes the principal safety and effectiveness
> results. Patients treated with PMR experienced statistically
> significant improvements in angina, exercise tolerance test duration
> and quality of life. There was no significant difference in mortality
> or serious adverse events between the groups. The ejection fraction
> and wall motion scores at 3 months were not significantly different
> than at baseline, demonstrating that the PMR procedure did not
> adversely affect left ventricular function.
>
> **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                     | 7.0% (n=7)  | 2.0% (n=2)   | 0.170  |
+-------------------------------+-------------+--------------+--------+
| Exercise Tolerance            | 50.8 (n=99) | -6.4 (n=97)  | 0.014  |
| Improvement (seconds)         |             |              |        |
+-------------------------------+-------------+--------------+--------+
| Quality of Life Improvement   | 12.3 (n=95) | 10.4(n=95)   | \      |
| (SAQ)                         |             |              | <0.001 |
|                               | 26.0 (n=96) | 4.2 (n=96)   |        |
| Physical Limitation Scale     |             |              | \      |
|                               | 19.3 (n=95) | 7.1 (n=97)   | <0.001 |
| Anginal Stability Scale       |             |              |        |
|                               | 9.4 (n=96)  | 1.7 (n=97)   | \      |
| Anginal Frequency Scale       |             |              | <0.003 |
|                               | 28.5 (n=96) | 9.1 (n=97)   |        |
| Treatment Satisfaction Score  |             |              | \      |
|                               |             |              | <0.001 |
| Disease Perception Score      |             |              |        |
|                               |             |              | \      |
|                               |             |              | <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.

All patients in the Randomized Trial (n=275)

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

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

                                                          

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

There were no intra-procedural deaths in the PACIFIC 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 subjects in the MEDs
group died (both due to cardiac causes).

> The results of the PACIFIC Study are supported by the results of the
> BELIEF Study, a double blinded comparison between PMR+MEDS and Sham
> treatment (Sham+MEDs). In the BELIEF Study 41% (16/39) of the PMR
> treated patients experienced [\>]{.underline} 2 class improvement in
> angina compared with 13% (5/39) of the Sham treated patients. There
> was one intra-procedural death in the Sham+MEDs group and another at 3
> months (5%; 2/42). There were no deaths in the PMR treated group
> (0/40; p=0.49). There was one myocardial perforation requiring
> pericardiocentesis in the PMR+MEDs group and one instance of
> pericardial effusion at 3 months follow-up in the Sham group. There
> were 2 episodes of TIA in the Sham group and none in the PMR group and
> there were no MI in either group. Other adverse events included extra
> systole ventricular arrhythmias, groin complications, need for
> analgesics, and hospitalizations. There was no significant difference
> between the two groups for any of the adverse events.

# 7. PATIENT SELECTION AND TREATMENT

## Specific Patient Populations

> 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, 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 or;

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

# 8. PATIENT COUNSELING INFORMATION {#patient-counseling-information .unnumbered}

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 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

-   perforation and;

-   death.

# 9. CONFORMANCE TO STANDARDS {#conformance-to-standards .unnumbered}

The New Star Laser has been tested to and conforms with the requirements
of the following domestic and international standards:

-   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

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-   EN55011:1998 Class A, the European Electromagnetic Emissions
    Standard

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-   IEC 825-1 Radiation Safety of Laser Products & Equipment

> 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 Electromagnetic Immunity

-   EN 61000-4-4, 1995-01 Electrical Fast Transient/Burst Immunity

-   En 50141 1994 Conducted Disturbance Induced by RF Fields

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

## 10.1 Packaging

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

-   The New Star Laser and ECG monitor are initially installed in the
    hospital by Eclipse personnel.

-   The single-use delivery systems are supplied sterile for every PMR
    case. 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 appropriate procedures (see Section
    4).

## 10.2 Storage

All 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.

## 10.3 Axcis PMR Delivery Systems

Axcis Laser Catheter fiberoptic which delivers laser energy

Axcis Aligning Catheter Ultra-1, Ultra-1 Long Ultra-2, Ultra-3, and
Open-2 configurations to reach various cardiac anatomies

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
connector on the Laser Catheter

# 11. CLINICIAN USE INFORMATION {#clinician-use-information .unnumbered}

## 11.1 Patient Informed Consent

A PMR procedure-specific consent form must be signed by each patient to
ensure that the risks associated with PMR have been fully explained to
the patient.

## 11.2 Device Operating Instructions

Operating instructions for the laser and ECG monitor are contained in
the Eclipse PMR Holmium Laser User Manual which includes sections
describing the system specifications, operation of the laser, laser
safety, labeling, troubleshooting and calibration and ECG monitor
operation. It also contains a glossary of laser terms.

It is essential that the User Manual, especially those parts dealing
with laser safety, be read and understood before operating, maintaining,
or servicing this system. Failure to operate the New Star Laser in
accordance with the User Manual may result in serious injury.

Specific instructions for use are provided with each Axcis PMR Delivery
System device and these should be read in conjunction with this
Information For Use document.

## 11.3 Operator Training

Federal law restricts the use of this device to practitioners who have
been trained in percutaneous myocardial revascularization including
laser system operation. Operator training for use of the Eclipse PMR
System must include training in the use of the laser system and the
fiberoptic delivery systems, 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

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-   PMR procedures

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-   laser safety and operation

    Further information about training can be obtained from an Eclipse
    Surgical Technologies, Inc. representative at 800-741-7062.

## 11.4 Mechanism of Action

The mechanism(s) whereby myocardial revascularization relieves angina is
not known. Current theories include:

-   Increased collateralization via angiogenesis;

-   Symptom reduction resulting from disruption of pain fiber function;

-   Increased perfusion of myocardium by the channels created

-   Placebo effect

# 12. PATIENT'S MANUAL

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