Spectranetics NS10036293 Руководство пользователя
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- Руководство пользователя
P019002-00 17FEB21 (2021-02-17)
1
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)
2
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)
3
0.9 mm RX X-80 Catheter Models
English / English
Instructions for Use - Sections by Language
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ELCA
Coronary Laser
Atherectomy Catheter
Instructions for Use
P019002-00 17FEB21 (2021-02-17)
4
0.9 mm RX X-80 Catheter Models
English / English
Table of Contents
1.
Description
...................................................................................................................4
2.
Indications for Use
..........................................................................................................5
3.
Contraindications
...........................................................................................................5
4.
Warnings
......................................................................................................................5
5.
Precautions
..................................................................................................................6
6.
Potential Adverse Events
..............................................................................................6
7.
Clinical Studies
..............................................................................................................7
8.
Individualization of Treatment
................................................................................13
9.
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
1.
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)
5
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
4
135 ± 5
2.
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.
3.
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.
4.
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)
6
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.
5.
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
6.
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)
7
0.9 mm RX X-80 Catheter Models
English / English
7.
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
p
Patients
66
72
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)
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0.9 mm RX X-80 Catheter Models
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Table 7.1.2 Lesion Characteristics and Procedural Details
ELCA
PTCA
p
Patients
66
72
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
0
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
0
0
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
p
p
p
Patients
66
72
Any dissection
Any dissection
7 (10.6%)
8 (11.1%)
1.000
Acute thrombus
0
0
Haziness
2 (3.0%)
5 (6.9%)
0.444
No Re ow
0
0
Arrhythmia
Arrhythmia
0
1 (1.4%)
1.000
Acute Vessel Closure
0
0
Occlusion of Side Branch
0
0
Occlusion Non-target
1 (1.5%)
0
0.478
Coronary Spasm
Coronary Spasm
2 (3.0%)
0
0.227
Coronary Embolism
Coronary Embolism
1 (1.5%)
0
0.478
Coronary Perforation
Coronary Perforation
3 (4.5%)
1 (1.4%)
0.349
Other
4 (6.1%)
2 (2.8%)
0.426
Laser/stent damage
0
n/a
Balloon/stent damage
Balloon/stent damage
2 (3.0%)
6 (8.3%)
0.278
Table 7.1.4 Procedural Complications – Bail-out Stenting
ELCA
PTCA
p
Patients
66
72
Any Bail-out Stenting
Any Bail-out Stenting
12 (18.8%)
8 (11.1%)
0.209
Why bailed-out?
Why bailed-out?
Residual Narrowing
1 (8.3%)
3 (37.5%)
Ischemia with ST changes or C dissection
0
0
D, E or F dissection
1 (8.3%)
2 (25.0%)
1.000
Reduction of TIMI ow at least 1 grade from
baseline
0
0
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)
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0.9 mm RX X-80 Catheter Models
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Table 7.1.5 Quantitative Coronary Angiography and Late Total Occlusion
ELCA
PTCA
p
Patients
Pre-Procedure
61
69
Post-Procedure
60
69
Follow-up
26
23
Reference Diameter
mm (SD)
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)
2.7 (0.5)
0.891
Mean MLD
mm (SD)
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)
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
p
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%)
3 (5.0%)
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)
10
0.9 mm RX X-80 Catheter Models
English / English
Table 7.1.7 CEC Adjudicated Clinical Endpoints through 30 Days
ELCA
PTCA
p
Through Discharge:
Patients with Data
66
72
CABG
2 (3.0%)
0
0.137
PCI
1 (1.5%)
0
0.295
Death
2 (3.0%)
0
0.137
Myocardial Infarction
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
0.137
MACE
12 (18.2%)
4 (5.6%)
0.021
Through 30 Days:
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
0.137
Myocardial Infarction
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
p
Patients with Data
66
72
CABG
2 (3.0%)
0
0.227
PCI
1 (1.5%)
0
0.478
Death
2 (3.0%)
0
0.227
Myocardial Infarction
Myocardial Infarction
2 (3.0%)
2 (2.8%)
1.000
Target Vessel Revasc.
3 (4.6%)
0
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
p
Through 6 Months:
Patients with Data
60
66
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
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:
59
65
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
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)
11
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
p
Age (years)
Age (years)
60 ± 12
63 ± 11
0.100
Males
52 (75%)
68 (68%)
0.688
Smoking
44 (64%)
68 (68%)
0.921
Hypertension
Hypertension
44 (64%)
72 (72%)
0.628
Diabetes
21 (30%)
41 (41%)
0.465
Hypercholester.
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
n=
69
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
p
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
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)
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
n=
69
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
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0.9 mm RX X-80 Catheter Models
English / English
Table 7.2.3 Quantitative Coronary Analysis*
PTCA+Ir192
ELCA+Ir192
p
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
Binary Restenosis
18 (53%)
29 (64%)
0.726
n=
34
45
*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
p
p
p
30 days
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
n=
69
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)
13
0.9 mm RX X-80 Catheter Models
English / English
8.
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.
9.
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 60C or
140F).
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
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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)
15
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)
16
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)
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)
18
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)
19
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)
20
RX X-80 0,9
Russian / P
1.
(RX)
, .
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ELCA
Spectranetics CVX-300
.
,
,
( — ,
).
Spectranetics
.
— .
— ()
.
— , .
1. (RX)
1. (RX)
, 9
, 9
..........................................................................................................................................
20
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21
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37
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Spectranetics NS10036293 Руководство пользователя
- Тип
- Руководство пользователя
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- English: Spectranetics NS10036293 User manual
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