Spectranetics NS10036293 Руководство пользователя

Бренд: Spectranetics

Модель: NS10036293

Тип: Руководство пользователя

P019002-00 17FEB21 (2021-02-17)

Instructions for Use

0.9 mm RX X-80 Catheter Models

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

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ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

Instructions for Use - Sections by Language

Language

Instructions For Use

English

Instructions For Use

Russian

P 

 



ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

Table of Contents

Description

...................................................................................................................4

Indications for Use

..........................................................................................................5

Contraindications

...........................................................................................................5

Warnings

......................................................................................................................5

Precautions

..................................................................................................................6

Potential Adverse Events

..............................................................................................6

Clinical Studies

..............................................................................................................7

Individualization of Treatment

................................................................................13

Operator’s Manual

.......................................................................................................13

10.

How Supplied

.............................................................................................................13

11.

Compatibility

.............................................................................................................14

12.

Directions for Use

.........................................................................................................14

13.

Manufacturer’s Limited Warranty

..................................................................................17

14.

Non-Standard Symbology

............................................................................................18

15.

Applicable Standards

...................................................................................................18

16.

Disposal

......................................................................................................................19

Description

Rapid exchange (RX) catheters

consists of optical  bers encased within a polyester shaft. There are two major

portions of the laser catheter shaft, the proximal portion which terminates at the laser connector, and the distal

portion which terminates at the tip having direct patient contact. The  bers terminate at the distal tip within

a polished adhesive end and at the proximal end within the laser connector. A radiopaque marker is located

on the distal end of the laser catheter to aid localization within the coronary vasculature in conjunction with

 uoroscopy. The guidewire lumen begins at the distal tip and is concentric with the  ber array, and exits the

laser catheter 9 cm away from the distal tip which has direct patient contact. A proximal marker is located on the

outer jacket of the laser catheter, 104 cm from the distal tip, to assist in the placement of the laser catheter within

a femoral guiding catheter without the need for  uoroscopy. When connected to the CVX-300 Excimer Laser

System, the operating parameters are:  uence 30-80 mJ/mm2 at a pulse rate of 25-80 Hz.

Mechanism of Action for ELCA Catheters

The multi ber laser catheters transmit ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System

to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photoablate

 brous, calci c, and atheromatous lesions, thus recanalizing diseased vessels (photo ablation is the process

by which energy photons cause molecular bond disruption at the cellular level without thermal damage

to surrounding tissue). The Spectranetics laser catheters have a proprietary lubricious coating to ease their

trackability through coronary vessels.

Glossary of Special Terms

Antegrade Fashion = In the direction of blood  ow.

Baseline Angiography = Record of the cardiac muscle and blood vessels prior to a given interventional

angioplasty procedure.

Retrograde Fashion = In the direction opposite to blood  ow.

Figure 1: Rapid Exchange (RX)

9 cm Guidewire Lumen

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

Table 1.1 ELCA X-80 Coronary Laser Atherectomy Catheter Models (RX)

Device

Description

Model

Number

Max. Guidewire

Compatibility

(in.)

Max. Tip

Diameter

(in.)

Max. Tip

Diameter

(mm)

Sheath

Compatibility

(Fr)

Working

Length

(cm)

Rapid Exchange (RX) Catheter Speci cations

0.9 mm

110-004

0.014

0.038

0.97

135 ± 5

Indications for Use

The X-80 Laser Catheters used in conjunction with the Spectranetics CVX-300 Excimer Laser System are intended

for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in

conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable

candidates for coronary artery bypass graft (CABG) surgery. Adjunctive balloon angioplasty was performed,

at the clinical investigator’s discretion, for 85% of the lesions treated. The following

Indications for Use,

Contraindications and Warnings

have been established through multicenter clinical trials. Clinical experience

has provided reasonable assurance that the Spectranetics CVX-300 Excimer Laser System and the multi ber laser

catheter models are safe and e ective for the following indications:

•

Occluded saphenous vein bypass grafts

•

Ostial lesions

•

Long lesions - (greater than 20 mm in length)

•

Moderately calci ed stenoses - (Heavily calci ed stenoses are those lesions that demonstrate complete

calci cation when identi ed under  uoroscopy by angiography prior to the procedure. Moderately and

slightly calci ed stenoses are all others.)

•

Total occlusions traversable by a guidewire

•

Lesions which previously failed balloon angioplasty - (This includes those lesions that were treated

unsuccessfully by PTCA. Lesions that have undergone a complicated PTCA procedure are not included in

this category.)

These lesions must be traversable by a guidewire and composed of atherosclerotic plaque and/or calci ed

material. The lesions should be well de ned by angiography.

Contraindications

•

Patient has acute thrombosis.

•

Lesion is in an unprotected left main artery.

•

Patient has experienced an acute myocardial infarction.

•

Patient has ejection fraction of less than 30%.

•

Lesion is beyond acute bends or is in a location within the coronary anatomy where the catheter cannot

traverse.

•

Guidewire cannot be passed through the lesion.

•

Lesion is located within a bifurcation.

•

Patient is not an acceptable candidate for bypass graft surgery.

Warnings

Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training.

A clinical investigation of the Spectranetics CVX-300 Excimer Laser System did not demonstrate safety and

e ectiveness in lesions amenable to routine PTCA or those lesions not mentioned in the Indications for Use,

above.

The e ect of adjunctive balloon angioplasty on restenosis, as opposed to laser alone, has not been studied.

Physicians should exercise care when treating patients for coronary artery disease with the CVX-300 Excimer

Laser System.

Spectranetics Coronary Laser Atherectomy Catheter require CVX-300 software version 3.712 or 3.812 or higher.

The use of the CVX-300 Excimer Laser System is restricted to physicians who are trained in angioplasty,

Percutaneous Transluminal Coronary Angioplasty (PTCA) and who meet the training requirements listed below.

These requirements include, but are not limited to:

1. Training of laser safety and physics.

2. Review of patient  lms of lesions that meet the indications for use.

3. A review of cases demonstrating the ELCA technique in lesions that meet the indications for use.

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

4. A review of laser operation followed by a demonstration of the CVX-300 Excimer Laser System.

5. Hands on training with the CVX-300 Excimer Laser System and appropriate model.

6. A fully trained Spectranetics representative will be present to assist for a minimum of the  rst two cases.

7. Following the formal training session, Spectranetics will make available additional training if so requested

by the physician, support personnel, the institution or Spectranetics.

Precautions

This catheter has been sterilized using Ethylene Oxide and is supplied STERILE. The device is designated and

intended for

SINGLE USE ONLY

and must not be resterilized and/or reused.

DO NOT resterilize or reuse this device, as these actions can compromise device performance or increase

the risk of cross-contamination due to inappropriate reprocessing.

Reuse of this single use device could lead to serious patient injury or death and voids manufacturer

warranties.

The sterility of the product is guaranteed only if the package is unopened and undamaged. Prior to use, visually

inspect the sterile package to ensure that the seals have not been broken. Do not use the catheter if the integrity

of the package has been compromised. Do not use catheter product if its “Use Before Date,” found on package

labeling, has been passed.

Before use, examine carefully all of the equipment to be used in the procedure for defects. Do not use any

equipment if it is damaged.

After use, dispose of all equipment in accordance with applicable speci c requirements relating to hospital

waste, and potentially biohazardous materials.

Read the Operator’s Manual (7030-0035 or 7030-0068) thoroughly before operating the CVX-300 Excimer Laser

System. Pay particular attention to the Warnings and Responsibility section of the manual which explains Notes,

Cautions, and Warnings to be followed to ensure safe operation of the system.

During the procedure, appropriate anticoagulant and coronary vasodilator therapy must be provided to the

patient. Anticoagulant therapy should be administered per the institution’s PTCA protocol for a period of time to

be determined by the physician after the procedure.

Percutaneous Excimer Laser Coronary Atherectomy (ELCA) should be performed only at hospitals where

emergency coronary bypass graft surgery can be immediately performed in the event of a potentially injurious

or life threatening complication.

The results of clinical investigation indicated that patients with the following conditions are at a higher risk for

experiencing acute complications:

•

Patients with diabetes

•

Patients with a history of smoking

•

Lesions within tortuous vessels

Potential Adverse Events

Use of the Spectranetics CVX-300 Excimer Laser System may contribute to the following complications:

•

Dissection of the arterial wall

•

Perforation

•

Acute reclosure

•

Embolization

•

Aneurysm formation

•

Spasm

•

Coronary artery bypass graft surgery

•

Thrombus

•

Myocardial infarction

•

Arrhythmia

•

Filling defects

•

Death

No long term adverse e ects of ELCA are known at this time.

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

Clinical Studies

7.1 COMPARISON OF ELCA+PTCA TO PTCA ALONE IN RESTENOSED STENTS

The Laser Angioplasty of Restenosed Stents (LARS) randomized trial was initiated to compare ELCA+PTCA to

PTCA alone in di use (10-40mm) in-stent restenosis. First instances of restenosis in a subset of commercially

available stainless steel stents were treated, with the primary endpoint being absence of Major Adverse Cardiac

Events (MACE) at 6 months. An interim analysis of acute results was undertaken to obtain data to support the

indication of ELCA in stents prior to the administration of intravascular brachytherapy. Following approval of

the indication, LARS Trial recruitment was concluded after enrollment of 138 of the planned 320 patient study

group. Sixty-six (66) patients were allocated to the excimer laser group and 72 patients were allocated to the

balloon only control group. This cohort represents 43% of the planned study group. Due to the abbreviated study

group and underpowered nature of the study analysis, statistical inferences cannot be  nalized and accidental

signi cance can occur.

Analysis:

Baseline characteristics of 138 LARS patients were similar between the two groups. Trends were observed toward

a higher incidence of prior myocardial infarction in the PTCA group and diabetes in the ELCA group. Lesion

characteristics and locations were also similar, with approximately 83% of lesions having 11 - 20 mm length.

Procedural success was equivalent in both groups. Quantitative coronary angiography (QCA) did not reveal

di erences between groups in pre- and post-procedural lumen diameters. At 6-month follow-up, in a subgroup

of 49 patients who received a 6-month angiographic restudy, prior to removal of the protocol requirement, there

was a trend towards improved percent diameter stenosis and fewer late total occlusions in the control group.

Similar procedural complications were observed in the two groups. In the PTCA-only group, there was a mild

trend towards more balloon-induced dissection and stent damage in the form of stent strut distortion and

changes in stent:vessel wall apposition. Adjudicated incidences of MACE were tabulated at hospital discharge,

30-day, 6- and 9-month follow-up intervals. There was a trend towards higher incidences of MACE in the ELCA

group at each interval. This incidence was primarily driven by a higher rate of non-Q-wave myocardial infarction.

In the ELCA group, two in-hospital deaths were observed, one secondary to renal failure and one secondary to

chronic obstructive pulmonary disease (COPD).

Table 7.1.1 Baseline Characteristics

ELCA

PTCA

Patients

Age (years)

Mean (S.D.)

62.9 (12.0)

64.2 (11.7)

0.540

Females

20 (30.3%)

23 (31.9%)

0.835

Current Smoking

15 (23.8%)

12 (17.1%)

0.340

Diabetes

27 (41.5%)

22 (30.6%)

0.180

Hypertension

48 (72.7%)

58 (80.6%)

0.276

Hypercholesterolemia

53 (80.4%)

54 (76.1%)

0.548

Canadian Classi cation

No angina

Class I

Class II

Class III

Class IV

2 (3.0%)

10 (15.2%)

13 (19.7%)

20 (30.3%)

21 (31.8%)

2 (2.8%)

12 (16.7%)

20 (27.8%)

18 (25.0%)

20 (27.8%)

0.820

Prior MI

23 (43.4%)

31 (55.4%)

0.212

Prior CABG

11 (20.8%)

13 (23.6%)

0.719

ELCA=excimer laser coronary angioplasty, PTCA=percutaneous transluminal coronary angioplasty,

MI=myocardial infarction, CABG=coronary artery bypass grafts

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

Table 7.1.2 Lesion Characteristics and Procedural Details

ELCA

PTCA

Patients

Culprit Vessel

LAD

18 (27.3%)

26 (36.1%)

0.649

LCX

21 (31.8%)

19 (26.4%)

RCA

21 (31.8%)

19 (26.4%)

SVG

6 (9.1%)

7 (9.7%)

Other

1 (1.4%)

Lesion Length

<10 mm

6 (9.4%)

3 (4.3%)

0.349

11-20 mm

53 (82.8%)

58 (82.9%)

21-30 mm

5 (7.8%)

9 (12.9%)

>30 mm

Procedural Success †

55 (85.9%)

64 (88.9%)

0.603

LAD=left anterior descending artery, LCX=left circum ex artery,

RCA=right coronary artery, SVG=saphenous vein graft

† Procedural success de ned as <50% stenosis without major in-hospital complications (death, myocardial

infarction, or coronary artery bypass surgery).

Table 7.1.3 Procedural Complications

ELCA

PTCA

Patients

Any dissection

7 (10.6%)

8 (11.1%)

1.000

Acute thrombus

Haziness

2 (3.0%)

5 (6.9%)

0.444

No Re ow

Arrhythmia

1 (1.4%)

1.000

Acute Vessel Closure

Occlusion of Side Branch

Occlusion Non-target

1 (1.5%)

0.478

Coronary Spasm

2 (3.0%)

0.227

Coronary Embolism

1 (1.5%)

0.478

Coronary Perforation

3 (4.5%)

1 (1.4%)

0.349

Other

4 (6.1%)

2 (2.8%)

0.426

Laser/stent damage

n/a

Balloon/stent damage

2 (3.0%)

6 (8.3%)

0.278

Table 7.1.4 Procedural Complications – Bail-out Stenting

ELCA

PTCA

Patients

Any Bail-out Stenting

12 (18.8%)

8 (11.1%)

0.209

Why bailed-out?

Residual Narrowing

1 (8.3%)

3 (37.5%)

Ischemia with ST changes or C dissection

D, E or F dissection

1 (8.3%)

2 (25.0%)

1.000

Reduction of TIMI  ow at least 1 grade from

baseline

Elective

5 (41.7%)

1 (12.5%)

Other

5 (41.7%)

2 (25.0%)

0.478

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

Table 7.1.5 Quantitative Coronary Angiography and Late Total Occlusion

ELCA

PTCA

Patients

Pre-Procedure

Post-Procedure

Follow-up

Reference Diameter

mm (SD)

Pre-Procedure

2.8 (0.6)

2.6 (0.5)

0.014

Post-Procedure

2.8 (0.5)

2.6 (0.5)

0.059

Follow-up

2.7 (0.5)

0.891

Mean MLD

mm (SD)

Pre-Procedure

0.9 (0.5)

0.8 (0.4)

0.284

Post-Procedure

2.2 (0.5)

2.1 (0.6)

0.499

Follow-up

0.9 (0.7)

1.5 (0.6)

0.008

% Diameter Stenosis

mean (SD)

Pre-Procedure

67.0 (13.7)

67.4 (13.4)

0.860

Post-Procedure

22.8 (10.5)

20.7 (13.6)

0.340

Follow-up

64.6 (26.9)

45.9 (17.3)

0.006

Late Total Occlusion*

6 (20.7%)

1 (4.2%)

0.077

MLD=minimum lumen diameter

* Angiographically documented total occlusion at the lesion site >30 days and within 6 months of the index

procedure.

Table 7.1.6 Anginal Functional Class

ELCA

PTCA

Baseline

No angina

Class I

Class II

Class III

Class IV

2 ( 3.0%)

10 (15.2%)

13 (19.7%)

20 (30.3%)

21 (31.8%)

2 (2.8%)

12 (16.7%)

20 (27.8%)

18 (25.0%)

20 (27.8%)

0.820

Month 1

No angina

Class I

Class II

Class III

Class IV

32 (53.3%)

19 ( 31.7%)

3 (5.0%)

42 (60.0%)

17 (24.3%)

5 (7.1%)

4 (5.7%)

2 (2.9%)

0.819

Month 6

No angina

Class I

Class II

Class III

Class IV

30 (52.6%)

11 (19.3%)

10 (17.5%)

5 (8.8%)

1 (1.8%)

35 (58.3%)

15 (25.0%)

5 (8.3%)

1 (1.7%)

4 (6.7%)

0.133

Month 9

No angina

Class I

Class II

Class III

Class IV

35 (62.5%)

10 (17.9%)

7 (12.5%)

3 (5.4%)

1 (1.8%)

34 (58.6%)

13 (22.4%)

6 (10.3%)

4 (6.9%)

1 (1.7%)

0.964

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

Table 7.1.7 CEC Adjudicated Clinical Endpoints through 30 Days

ELCA

PTCA

Through Discharge:

Patients with Data

CABG

2 (3.0%)

0.137

PCI

1 (1.5%)

0.295

Death

2 (3.0%)

0.137

Myocardial Infarction

11 (16.7%)

4 (5.6%)

0.036

Non-Q-wave MI

9 (13.6%)

3 (4.2%)

Target Vessel Revasc.

2 (3.0%)

0.137

MACE

12 (18.2%)

4 (5.6%)

0.021

Through 30 Days:

Patients with Data:

47 65

55 72

CABG

2 (3.0%)

2 (2.8%)

0.930

PCI

2 (3.0%)

1 (1.4%)

0.509

Death

2 (3.0%)

0.137

Myocardial Infarction

13 (19.7%)

5 (6.9%)

0.026

Non-Q-wave MI

11 (16.6%)

4 (5.5%)

Target Vessel Revasc.

3 (4.5%)

3 (4.2%)

0.913

MACE

14 (21.2%)

7 (9.7%)

0.061

Table 7.1.8 Investigator-Indicated Clinical Endpoints at Discharge

ELCA

PTCA

Patients with Data

CABG

2 (3.0%)

0.227

PCI

1 (1.5%)

0.478

Death

2 (3.0%)

0.227

Myocardial Infarction

2 (3.0%)

2 (2.8%)

1.000

Target Vessel Revasc.

3 (4.6%)

0.107

MACE

5 (7.6%)

2 (2.8%)

0.259

Table 7.1.9 CEC Adjudicated Clinical Endpoints through 6 and 9 Months

ELCA

PTCA

Through 6 Months:

Patients with Data

CABG

6 (9.7%)

4 (5.9%)

0.406

PCI

15 (25.3%)

9 (13.7%)

0.082

Death

2 (3.2%)

1 (1.5%)

0.491

Myocardial Infarction

13 (19.7%)

5 (6.9%)

0.026

Non-Q-wave MI

11 (16.6%)

4 (5.5%)

Target Vessel Revasc.

18 (29.8%)

13 (19.6%)

0.151

MACE

24 (38.1%)

18 (26.5%)

0.093

Through 9 Months:

Patients with Data:

CABG

6 (9.7%)

5 (7.5%)

0.615

PCI

18 (30.7%)

14 (22.0%)

0.185

Death

4 (6.6%)

1 (1.5%)

0.142

Myocardial Infarction

13 (19.7%)

6 (8.5%)

0.050

Non-Q-wave MI

11 (16.6%)

5 (6.9%)

Target Vessel Revasc.

21 (35.2%)

19 (29.6%)

0.352

MACE

28 (45.1%)

25 (37.6%)

0.198

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

7.2 COMPARISON OF ELCA AND PTCA PRIOR TO BRACHYTHERAPY

The following data has been reported by the investigators participating in the Washington Radiation for In-

Stent Restenosis Trial (WRIST). Patient data presented in the following tables were compiled from WRIST, Long

WRIST (long in-stent restenosis lesions 36-80mm), the γ radiation registries including Long WRIST High Dose

(long in-stent restenosis lesions 36-80mm using 18 Gy at 2mm), Plavix WRIST (6 months Clopidogrel therapy post

coronary intervention and radiation), Compassionate WRIST (intracoronary localized radiation compassionate

protocol for prevention of recurrence of restenosis) and WRIST X-over group (patients who initially failed placebo

therapy and were subsequently treated with radiation). All WRIST studies were conducted under an IDE following

patient informed consent and were independently monitored.

Analysis: To make a direct comparison of outcomes between PTCA and ELCA prior to Ir192 brachytherapy

for in-stent restenosis, the data analysis was restricted to patients treated with PTCA+Ir192 and ELCA+Ir192.

Comparisons between continuous variables were made with a 2-sided T-test and between dichotomous

variables with a 2-sided continuity-corrected chi-squared test. A value of p<.05 was considered signi cant.

Baseline characteristics were similar between the two groups, with a trend toward more LCX lesions treated in

the PTCA+Ir192 group, but no signi cant di erences in lesion characteristics were evident.

Table 7.2.1 Baseline Characteristics*

PTCA+Ir192

ELCA+Ir192

Age (years)

60 ± 12

63 ± 11

0.100

Males

52 (75%)

68 (68%)

0.688

Smoking

44 (64%)

68 (68%)

0.921

Hypertension

44 (64%)

72 (72%)

0.628

Diabetes

21 (30%)

41 (41%)

0.465

Hypercholester.

52 (75%)

75 (75%)

0.992

Unstable Angina

55 (80%)

82 (82%)

0.985

Previous MI

40 (58%)

55 (55%)

0.975

Previous CABG

54 (78%)

70 (70%)

0.596

Multivessel disease

53 (77%)

63 (63%)

0.223

Prior restenosis

35 (51%)

67 (67%)

0.145

LVEF

0.47 ± 0.1

0.45 ± 0.1

0.203

100

*PTCA = percutaneous transluminal coronary angioplasty, Ir = Iridium, ELCA = excimer laser coronary angioplasty,

MI = myocardial infarction, CABG = coronary artery bypass grafting, LVEF = left ventricular ejection fraction

Table 7.2.2 Lesion Characteristics and Procedural Details*

PTCA+Ir192

ELCA+Ir192

Culprit vessel

LAD

8 (12%)

19 (19%)

0.559

LCX

21 (31%)

15 (15%)

0.086

RCA

19 (27%)

26 (26%)

0.999

SVG

17 (25%)

38 (38%)

0.254

Type B2/C

36 (52%)

37 (37%)

0.198

Lesion length mm

24 ± 11

25 ± 11.4

0.568

Ref Vess Dia mm

3.3 ± 0.6

3.4 ± 0.9

0.387

Dose (Gy)

14.3 ± 0.7

14.4 ± 0.5

0.309

Proc. Success†

69 (100%)

100 (100%)

1.000

Complications

6 (9%)

6 (6%)

0.935

100

*PTCA = percutaneous transluminal coronary angioplasty, Ir = Iridium, ELCA = excimer laser coronary angioplasty,

LAD = left anterior descending artery, LCX = left circum ex artery, RCA = right coronary artery, SVG = saphenous

vein graft, B2/C = modi ed AHA/ACC Lesion Classi cation Score, mm = millimeter, Gy = gray

†Procedure success de ned as <50% stenosis without major in-hospital complications (death, myocardial

infarction, or coronary artery bypass surgery).

Angiographic analysis was reported for approximately half of the patients treated in the two groups.

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

Table 7.2.3 Quantitative Coronary Analysis*

PTCA+Ir192

ELCA+Ir192

Ref Dia mm

Pre

2.9 ± 0.6

2.7 ± 0.6

0.146

Post

2.9 ± 0.6

2.8 ± 0.5

0.434

F-Up

2.9 ± 0.6

3 ± 0.6

0.466

MLD mm

Pre

1.2 ± 0.5

0.9 ± 0.6

0.018

Post

2 ± 0.5

1.9 ± 0.5

0.382

F-Up

1.9 ± 0.9

1.6 ± 0.9

0.146

DS%

Pre

57 ± 20

66 ± 20

0.051

Post

30 ± 12

33 ± 12

0.275

F-Up

36 ± 20

46 ± 25

0.052

Late Loss mm

0.2 ± 0.7

0.3 ± 0.8

0.556

Loss index

0.4 ± 1.4

0.2 ± 0.8

0.458

Binary Restenosis

18 (53%)

29 (64%)

0.726

*PTCA = percutaneous transluminal coronary angioplasty, Ir = Iridium, ELCA = excimer laser coronary angioplasty,

Ref Dia = reference diameter, mm = millimeter, MLD = minimum luminal diameter, DS% = percent diameter

stenosis, Late Loss de ned as the change in the lesion MLD from the  nal to the follow-up angiogram. Loss Index

(within the lesion) de ned as late loss/acute gain. Binary Restenosis (at follow-up, 4-8 months angiogram after

treatment) de ned as ≥50% diameter narrowing within the segment including the stent and its edges (within

5 mm).

Clinical outcomes appear to be similar between the two groups. Overall TLR, TVR, and MACE rates were very

similar between the two groups. More Late Total Occlusions (LTO) were observed in the PTCA+Ir192 group.

Table 7.2.4 Clinical Outcomes*

PTCA+Ir192

ELCA+Ir192

30 days

MACE

1 (1%)

2 (2%)

0.948

6 months

Death

1 (1%)

5 (5%)

0.403

QMI

0 (0%)

2 (2%)

0.514

NQMI

9 (13%)

18 (18%)

0.515

TLR

13 (19%)

16 (16%)

0.784

TVR

23 (33%)

25 (25%)

0.314

PTCA

21 (30%)

22 (22%)

0.290

CABG

9 (13%)

8 (8%)

0.418

LTO

6 (9%)

1 (1%)

0.019

MACE

24 (35%)

29 (29%)

0.530

100

*PTCA = percutaneous transluminal coronary angioplasty, Ir = Iridium, ELCA = excimer laser coronary angioplasty,

MACE = major adverse cardiac events (death, Q-wave MI or TVR), QMI = Q-wave myocardial infarction, NQMI =

non-Q-wave MI, TLR = target lesion revascularization, TVR = target vessel revascularization, CABG = coronary

artery bypass grafts, LTO = late total occlusion.

Death de ned as all-cause mortality.QMI or NQMI de ned as a total creatinine kinase elevation ≥2x normal value

and/or elevated creatinine kinase MB fraction ≥20 ng/ml with or without new pathological q waves (>.04 sec) in

two or more contiguous leads.

TVR and TLR as characterized by repeat percutaneous intervention (PTCA) or CABG involving the treated vessel,

driven clinical signs of ischemia in the presence of angiographic restenosis.

Late total occlusion de ned as angiographically documented total occlusion at the lesion site>30 days and

within 6 months of the index procedure.

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

Individualization of Treatment

The risks and bene ts described above should be carefully considered for each patient before use of ELCA.

Patient selection and clinical techniques should be conducted according to instructions provided in Section 2.,

“Indications for Use,” Section 7, “Clinical Studies,” and Section 12, “Directions for Use.”

References

1. Textbook of Interventional Cardiology. Topol, E.J. Editor, 4th Edition: 2003, Chapter 31 - Laser, Topaz, O., pp

675-703.

2. Excimer Laser Revascularisation: Current Indications, Applications and Techniques. Topaz, O., Lasers in

Medical Science: 2001: Vol. 16, pp 72-77.

3. E ectiveness of Excimer Laser Coronary Angioplasty in Acute Myocardial Infarction or in Unstable Angina

Pectoris. Topaz, O. et al. American Journal of Cardiology: Apr 1, 2001: Vol. 87, pp 849-855.

4. Application of Excimer Laser Angioplasty in Acute Myocardial Infarction. Topaz, O. et al, Lasers in Surgery

and Medicine: 2001: Vol. 29, pp 185-192.

5. Rescue Excimer Laser Angioplasty in Patients with Acute Myocardial Infarction - The CARMEL Study. Topaz,

O. et al. (manuscript on  le and currently under review for publication)

6. Excimer Laser – Assisted Coronary Angioplasty for Lesions Containing Thrombus. Estella, P. et al. Journal of

the American College of Cardiology: June 1993: Vol. 21: No. 7, pp 1550-1556.

7. Laser Angioplasty and Laser-Induced Thrombolysis in Revascularization of Anomalous Coronary Arteries.

Shah, R. et al. Journal of Invasive Cardiology: 2002: Vol. 14, pp 180-186.

8. Laser-Facilitated Thrombectomy: A New Therapeutic Option for Treatment of Thrombus-Laden Lesions.

Dahm, J. et al. Catheterization and Cardiovascular Interventions: 2002: Vol. 56, pp 365-372.

9. Comparison of E ectiveness of Excimer Laser Angioplasty in Patients with Acute Coronary Syndromes in

Those With – versus – Those Without Normal Left Ventricular Function. Topaz, O. et al. American Journal of

Cardiology: 2003: Vol. 91, pp 797-802.

Operator’s Manual

The devices described in this document can be operated within the following energy ranges on the CVX-300

Excimer Laser System:

Table 9.1 Energy Parameters

Device Description

Model No.

Fluence(mJ/mm



)

Repetition Rate

(Hz)

Laser On/O Time

(sec)

ELCA RX Catheter

0.9 mm X-80

110-004

30-80

25-80

10 / 5



Recommended calibration settings: 45 Fluence, 25 Hz.

10.

How Supplied

10.1 Sterilization

For single use only

. Do not re-sterilize and/or reuse.

The Spectranetics laser catheters have been sterlized using Ethylene Oxide and are supplied sterile. Sterility is

guaranteed only if the package is unopened and undamaged.

10.2 Transportation and Storage

Keep dry. Store in a cool dry place. Protect from direct sunlight and high temperature (greater than 60C or

140F).

10.3 Inspection Prior to Use

Before use, visually inspect the sterile package to ensure that seals have not been broken. All equipment to

be used for the procedure, including the catheter, should be examined carefully for defects. Examine the laser

catheter for bends, kinks or other damage. Do not use if it is damaged or unintentionally opened.

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

11. Compatibility

The Spectranetics Coronary Laser Atherectomy Catheter is designed and intended to be used exclusively with

the Spectranetics CVX-300 Excimer Laser System.

Do not use in combination with any other laser system.

Guidewire Compatibility

See Catheter Speci cation Table in Section 1.

12. Directions for Use

12.1 Procedure Set Up

Some or all of the following additional materials, which are not included in the laser catheter package, may be

required for the procedure (these are single use items only—do not resterilize or reuse):

•

Femoral guiding catheter(s) in the appropriate size and con guration to select the coronary artery

•

Hemostatic valve(s)

•

Sterile normal saline

•

Standard contrast media

•

0.014” guidewires

Turn on the laser unit. Verify that the number 38 is displayed on the panel at start up. This ensures the proper

software version, 3.8, is installed in the laser.

CAUTION: If 38 is not displayed at start up, do NOT use catheter and contact Spectranetics Field Service

immediately.

Using sterile technique, open the sterile package. Remove the packaging wedges from the tray and gently lift the

laser catheter from the tray while supporting the black laser connector, also known as the proximal end, proximal

coupler, or proximal connector. Please note that the proximal end of the laser catheter connects only to the CVX-

300 Excimer Laser System, and is not meant to have any patient contact.

Connect the proximal end of the laser catheter to the CVX-300 Excimer Laser System, and position the laser

catheter in the laser system extension pole or strain relief, whichever is supplied. Calibrate the laser catheter

following the instructions provided in the CVX-300 Excimer Laser System, Operator’s Manual (7030-0035 or 7030-

0068).

12.2 Clinical Technique

1. Use standard Percutaneous Seldinger Technique to insert an appropriate size introducer to accommodate

the guiding catheter, into the common femoral artery in a retrograde fashion. Heparinize intravenously

using the PTCA protocol for heparinization. Periodic measurement of activated clotting time (ACT greater

than 300 seconds) during the procedure will assist in maintaining optimum anticoagulation levels.

2. Introduce an appropriately sized guide catheter using the information provided in Table 1.1 (left or right

depending on the target coronary artery) using a standard 0.038” guidewire.

3. Perform baseline angiography by injecting contrast medium through the guiding catheter. Obtain

images in multiple projections, delineating anatomical variations and morphology of the lesion(s) to be

treated.

4. Introduce a 0.014” (or smaller) guidewire to the coronary arteries via the guiding catheter. Cross the

target lesion with the guidewire.

5. Size the laser catheter appropriately :

Table 12.2.1 Recommended Sizing

Catheter Size

Reference Vessel Diameter

0.9 mm

≥

2.0 mm

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

Figure 2: Rapid Exchange

Note: During use within the body, similar to any device used for vascular intervention, always monitor

Laser Catheter movement and the radiopaque tip marker position with  uoroscopy. The movement and

rate of advancement of the catheter distal tip should correspond directly with the rate of advancement

being applied to the proximal shaft of the catheter. If corresponding movement is not apparent, reassess

the lesion morphology, the laser energy being applied and the status of support equipment prior to

continued treatment.

6. Insertion techniques (Bare Wiring)

a. Monitor the guidewire position within the vasculature under  uoroscopy.

b. Insert the guidewire into the laser catheter by introducing the proximal end of the guidewire into the

distal tip of the laser catheter, and carefully advance the laser catheter, in small increments, to avoid

kinking the guidewire. Grasp the guidewire as it exits the proximal guidewire port and maintain its

position in the patient’s circulatory system while advancing the laser catheter.

c. Loosen the hemostatic valve of the y-adapter being used in conjunction with the introducer inserted

during step 1 above.

d. Carefully insert the laser catheter through the hemostatic valve of the y-adapter into the guide catheter

and advance the laser catheter to the guide catheter distal tip while maintaining the guidewire position.

e. Recon rm the guide catheter position in the ostium of the coronary artery with contrast media injection

and  uoroscopy prior to advancing the laser catheter.

f. Advance the laser catheter to the lesion site while maintaining the guidewire position in the patient’s

circulatory system. Inject contrast medium solution through the guiding catheter to verify the

positioning of the laser catheter under  uoroscopy.

7. Following con rmation of the laser catheter’s position in contact with the target lesion and using normal

saline or Lactated Ringer’s solution:

a. Flush all residual contrast media from the guide catheter and in-line connectors.

b. Flush all residual contrast media from the lasing site and vascular structures adjacent to the lasing site,

prior to activating the CVX-300 Excimer Laser System.

c. Please refer to the Saline Infusion Protocol and perform saline  ush and infusion per the instructions.

8. Depress the footswitch, activating the CVX-300 Excimer Laser System, and slowly, less than 1 mm per

second, advance the laser catheter allowing the laser energy to remove the desired material. Release the

footswitch to deactivate the CVX-300.

Note: Advancing the laser catheter through moderately calci ed lesions may require more pulses of laser

energy than  brous atherosclerotic tissue.

Caution: The tip of the laser catheter should not pass beyond the tip of the guidewire during the procedure.

Avoid pushing the laser catheter tip beyond the guidewire tip and/or withdrawing the guidewire inside

the laser catheter.

9. Pull back the laser catheter and inject contrast medium through the guiding catheter and examine the

lesion via  uoroscopy.

10. Repeat steps 7 through 9 as needed to complete treatment.

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

11. When withdrawing the laser catheter from the treated vessel, monitor the position of the guidewire in

the vessel with  uoroscopy to avoid guidewire prolapse, and exercise care while exiting the hemostatic

valve of the y-adapter with the distal tip of the laser catheter.

Note: If the laser catheter is removed from the vessel for any reason, thoroughly clean the laser catheter

outer surface and tip in heparinized saline to prevent blood from sticking. Blood remaining on the

laser catheter may diminish the e ciency of the laser catheter.

There is no need to remove the laser catheter from the patient in order to increase or decrease either the  uence

or pulse repetition rate; as the laser catheter was previously calibrated. Refer to the CVX-300 Excimer Laser

System Operator’s Manual, 7030-0035 or 7030-0068.

Note: All patients should be monitored for blood pressure and heart rate during the procedure.

12. Following laser atherectomy, perform follow-up angiography and balloon angioplasty, if needed.

13. The RX laser catheter has been speci cally designed for compatibility with rapid device exchanges as

needed during a single interventional surgery, done by the same surgical team. The RX laser catheter may

be quickly removed from the patient’s circulatory system, without removing the guidewire, as outlined

below.

1) Loosen the hemostatic valve.

2) Hold the guidewire and hemostatic valve in one hand, while grasping the laser catheter outer surface

in the other hand.

3) Maintain the guidewire’s position in the coronary artery by holding the guidewire stationary, and begin

pulling the laser catheter out of the guiding catheter.

Note: Monitor the guidewire position under  uoroscopy during the exchange.

4) Pull on the laser catheter withdrawing it until the opening in the guidewire lumen just exits the

Y-adapter. Carefully and slowly withdraw the last 9 cm of the  exible, distal portion of the laser catheter

o the guidewire while maintaining the guidewire’s position across the lesion. Close the hemostatic

valve.

5) Prepare the next laser catheter to be used, as previously described.

6) Again, insert the guidewire into the laser catheter by introducing the proximal end of the guidewire

into the distal tip of the laser catheter. The proximal portion of the guidewire, that will be handled by

the physician, will exit at the opening 9 cm from the distal tip.

7) Open the hemostatic valve and advance the laser catheter while maintaining guidewire position in the

coronary artery. Be careful not to twist the laser catheter around the guidewire.

8) Advance the laser catheter to the guiding catheter tip. Continue the laser angioplasty procedure, using

the previously described method.

14. Recommended pharmacology follow up to be prescribed by the physician.

Excimer Laser Saline Infusion Protocol

NOTE: This technique requires two operators. It is recommended that the primary physician-operator

advance the laser catheter and operate the laser system foot pedal. A scrub assistant should manage the

saline infusion control syringe and (if appropriate) depress the  uoroscopy pedal.

a. Before the laser procedure, warm a 500cc bag of 0.9% normal saline (NaCl) or lactated Ringer’s solution to

37°C. It is not necessary to add heparin or potassium to the saline solution. Connect the bag of warmed

saline to a sterile intravenous line and terminate the line at a port on a triple manifold.

b. Cannulate the ostium of the coronary artery or bypass graft with an appropriate “large lumen” guide

catheter in the usual fashion. It is recommended that the guide catheter

not

have side holes.

c. Under  uoroscopic guidance, advance the laser catheter into contact with the lesion. If necessary, inject

contrast to help position the tip of the laser catheter. If contrast appears to have become entrapped

between the laser catheter tip and the lesion, the laser catheter may be retracted slightly (1-2 mm) to

allow antegrade  ow and contrast removal while  ushing the system with saline.

(However, before

lasing, ensure that the laser catheter tip is in contact with the lesion.)

d. Expel any residual contrast from the control syringe back into the contrast bottle. Clear the triple manifold

of contrast by drawing up saline through the manifold into the control syringe.

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

e. Remove the original control syringe from the manifold and replace it with a fresh 20cc luer-lock control

syringe. This new 20cc control syringe should be primed with saline prior to connection to reduce the

chance for introducing air bubbles. (Merit Medical and other vendors manufacture 20cc control syringes.)

f. Flush all traces of blood and contrast from the manifold, connector tubing, y-connector, and guide

catheter, with at least 20-30cc of saline (several syringes of saline). When this initial  ushing is completed,

re ll the 20cc control syringe with saline.

g. Under  uoroscopy, con rm that the tip of the laser catheter is

in contact

with the lesion (advance the

laser catheter if necessary), but do

not

inject contrast.

h. When the primary operator indicates that he/she is ready to activate the laser system, the scrub assistant

should turn the manifold stopcock o to pressure and inject 10cc of saline as rapidly as possible (within

1-2 seconds). This bolus injection is to displace and/or dilute blood in the coronary tree down to the level

of the capillaries and limit back-bleeding of blood into the laser ablation  eld.

i. After the injection of the initial 10cc bolus and without stopping the motion of injection, the scrub

assistant should next slow down the rate of injection to 2-3cc/second. This portion of the saline infusion

is to displace and/or dilute the antegrade blood  ow entering the laser ablation  eld.

At the instant the

scrub assistant slows down the injection rate, the primary operator should activate the excimer

laser system by depressing the foot pedal and begin a lasing sequence.

j. The lasing sequence (train) should last for 2-10 seconds (maximum 10 seconds).

k. Terminate the saline injection at the end of the lasing train. Turn the manifold stopcock back to pressure

and re ll the control syringe with 20cc of saline in preparation for the next lasing sequence.

NOTE: Any electrocardiographic changes induced by saline infusion should be permitted to resolve

before repeating the sequence.

l. Each subsequent laser train should be preceded by a bolus of saline and performed with continuous

saline infusion as described in steps h-k.

m. If contrast is used to assess treatment results during the course of a laser treatment, repeat steps 4-7 prior

to reactivation of the excimer laser system (before activating the laser as described in steps h-k).

13. Manufacturer’s Limited Warranty

Manufacturer warrants that the ELCA coronary laser atherectomy catheter is free from defects in material and

workmanship when used by the stated “Use By” date. Manufacturer’s liability under this warranty is limited

to replacement or refund of the purchase price of any defective unit of the ELCA coronary laser atherectomy

catheter. Manufacturer will not be liable for any incidental, special, or consequential damages resulting from

use of the ELCA coronary laser atherectomy catheter. Damage to the ELCA coronary laser atherectomy catheter

caused by misuse, alteration, improper storage or handling, or any other failure to follow these Instructions

for Use will void this limited warranty.

THIS LIMITED WARRANTY IS EXPRESSLY IN LIEU OF ALL OTHER

WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTY OF MERCHANTABILITY OR

FITNESS FOR A PARTICULAR PURPOSE.

No person or entity, including any authorized representative or reseller

of Manufacturer, has the authority to extend or expand this limited warranty and any purported attempt to do

so will not be enforceable against the Manufacturer. This limited warranty covers only the ELCA coronary laser

atherectomy catheter. Information on Manufacturer’s warranty relating to the CVX-300 Excimer Laser System can

be found in the documentation relating to that system.

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

14. Non-Standard Symbology

Energy Range (mJ) at 45 Fluence

Max. Tip Diameter

Hydrophilic Coating

Sheath Compatibility

Quantity

QTY

Working Length

Importer

Max. Guidewire Compatibility

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

physician.

15. Applicable Standards

The standards identi ed in Table 15.1 were applied to the development of the device.

Table 15.1: Standards applied to the development of the ELCA.

Standard/Norm

and Date

Title

Biocompatibility:

ISO 10993-1

Biological evaluation of medical devices - Part 1: Evaluation of testing

Clinical Study:

EN ISO 14155

Clinical Investigation of medical devices for human subjects

Design:

ANSI Z136.1

Safe Use of Lasers

EN ISO 10555-1

Sterile, single-use intravascular catheters – Part 1: General requirements

US 21 CFR 820

Quality System Regulation

Environmental:

ISO 14644-1

Cleanrooms and associated controlled environments – Part 1: Classi cation of air

cleanliness.

ISO 14644-2

Cleanrooms and associated controlled environments – Part 2: Speci cation for

testing and monitoring to prove continued compliance with ISO 14644-1.

Labeling:

EN 556-1

Sterilization of Medical Devices. Requirements for medical devices to be designated

“STERILE”. Requirements for terminally sterilized medical devices.

EN 980

Graphical symbols for use in labeling of Medical Devices.

EN 1041

Information supplied by the manufacturer with medical devices

ISO 15223

Medical devices Symbols to be used with medical device labels, labeling and

information to be supplied

Packaging:

EN ISO 11607-1

Packaging for terminally sterilized medical devices - Part 1: Requirements for

materials, sterile barrier systems and packaging systems

ELCA

Coronary Laser

Atherectomy Catheter

Instructions for Use

P019002-00 17FEB21 (2021-02-17)

0.9 mm RX X-80 Catheter Models

English / English

Standard/Norm

and Date

Title

EN ISO 11607-2

Packaging for terminally sterilized medical devices - Part 2: Validation

requirements for forming, sealing and assembly processes

ISO 780

Packaging - Pictorial marking for handling of goods

Quality:

EN ISO 13485

Medical devices — Quality management systems

Risk Management:

EN ISO 14971

Medical Devices – Application of risk management to medical devices

EN 62366

Medical Devices - Application of usability engineering to medical devices

Sterilization:

EN ISO 11135

Sterilization of health care products - Ethylene oxide - Part 1: Requirements

for development, validation and routine control of a sterilization process

for medical devices

16. Disposal

Use and disposal must be in accordance with generally accepted medical practice and applicable local, state, and

federal laws and regulations.

Products may pose a potential biohazard after use.

If the packaging is damaged and / or the expiration date expires, the product is to be disposed of in accordance

with the rules for the treatment of medical waste class A according to SanPiN 2.1.7.2790-10.

The used product is disposed of in accordance with the rules for the management of medical waste class B

according to SanPiN 2.1.7.2790-10.

  

 

ELCA

 



P019002-00 17FEB21 (2021-02-17)

  RX X-80  0,9 

Russian / P 





   (RX)

   ,    .

      :  , 

  ,   ,   , 

    .     

          .

         

       .   

    ,        

  9    ,      .

          104   

          

   .       CVX-300

   :    30–80 /2    25–80 .

   ELCA

    Spectranetics CVX-300   

        .  

        , 

  ,       

( —  ,       

        ).  

Spectranetics         

   .

  

  —   .

  —    ()     

  .

  —  ,  .

 1.    (RX)

   , 9 



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 

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

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

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 

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  

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 

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 

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 

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 

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

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  

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  

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 

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 

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

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Spectranetics NS10036293 Руководство пользователя

Бренд: Spectranetics

Модель: NS10036293

Тип: Руководство пользователя

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