Individualization Of Treatment; How Supplied; Inspection Prior To Use; Compatibility - Spectranetics Turbo-Power Gebrauchsanweisung

7.3
Other Studies: CELLO Study
Study Summary: Data presented in this IFU were collected in support of safety and e ectiveness for Spectranetics brand Turbo-Booster™ and CLiRpath™
Turbo™ catheters. The CELLO (CLiRpath Excimer Laser System to Enlarge Lumen Openings) Study, IDE #G060015, enrolled 17 training cases and 48 analysis
patients or a total of 65 patients at 17 sites. The data presented combines the results from the training and analysis patients.
E ectiveness: The primary e ectiveness endpoint (≥ 20 percent reduction in percent diameter stenosis, on average, as assessed by an angiographic core
lab) for the analysis cohort demonstrated a 35 percent reduction in diameter stenosis using the Turbo-Booster system compared to pre-procedure in the
study. The secondary e ectiveness endpoint for acute procedural success (visual assessment of nal residual stenosis) was achieved in 98.5 percent of
patients as visually assessed by physician.
Table 7.3.1 Patient Demographics
Variable
Age (years) Age (years)
Gender (Male)
African-American
Caucasian
Hispanic
CAD
MI
Prior Coronary Revascularization Prior Coronary Revascularization
Diabetes
Hypertension Hypertension
Hyperlipidemia Hyperlipidemia
CVA
Table 7.3.2 Lesion Locations
Location of Vascular Lesions
Super cial Femoral Artery (SFA)
Popliteal Artery
Table 7.3.3 Procedure Information
NOTE: All values based on angiographic core laboratory analysis
Angiographic Results (n=65) Angiographic Results (n=65) Angiographic Results (n=65)
Reference vessel diameter (mm)
Average lesion length (mm)
Percent diameter stenosis – Pre
Percent diameter stenosis –
After Turbo-Booster use
Percent diameter stenosis – Final
Safety: The primary safety endpoint measured was the occurrence of major adverse events, de ned as clinical perforation, major dissection requiring
surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death at the time of procedure, prior to release from the hospital
(or 24 hours post-procedure, whichever comes rst) at 30 days, and six (6) months. The CELLO study had no major adverse events reported through
the six month follow-up. One CVA was reported at a 12 month follow-up. There were eleven Serious Adverse Events, only one probably related to the
investigational device and there were no Unanticipated Adverse Device E ects. Table 7.2.5 presents adverse events that occurred during the procedure
through hospital discharge.
Table 7.3.4 Serious Adverse Events (n=65 patients)
Not Related to
n=11 Investigational
Device
Severe 9
Moderate 1
Mild 0
Table 7.3.5 Acute Adverse Events (n=65 patients)
NOTE: All values are from procedural through discharge
Not Related to
n=10 Investigational
Major dissection (Grade
E or F)
Distal embolization
Hematoma/Bleeding
Other (Hematuria, Sinus
tachycardia, Discomfort in
treated leg post-procedure)
Conclusions: The e ectiveness of the Turbo-Booster was demonstrated by the signi cant reduction in percent diameter stenosis from baseline to post-
Turbo-Booster use. The 35 % reduction in the % diameter stenosis, on average, met the endpoint for showing a ≥20 % reduction in % diameter stenosis.
The study demonstrated that the Turbo-Booster is safe for the treatment of patients with stenosis and occlusions crossable by a guidewire in the
super cial femoral artery and popliteal artery as evident by no occurrence of major adverse events through the six-month follow-up.
8.

INDIVIDUALIZATION OF TREATMENT

The risks and bene ts described above should be carefully considered for each patient before the use of the Turbo-Power System.
Although it is recommended that the guidewire fully cross the target lesion, use of the Turbo-Power device may also be considered after initial
conventional crossing attempts with guidewires are unsuccessful due to:
• A rounded or eccentric occlusion stump de ecting the guidewire to a subintimal passage.
• The guidewire repeatedly being de ected into a large collateral branch ush with the occlusion stump.
• Calci cation obstructing completion of guidewire passage within the obstructed lumen.
• Additionally, recanalization of native arteries may be considered in patients presenting with occluded bypass grafts.
9.

HOW SUPPLIED

9.1
Sterilization
The Turbo-Power System is supplied sterile by the ethylene oxide sterilization process in a single sterile barrier consisting of tray and lid inside a peel-open
pouch. Intended for SINGLE USE ONLY; do not resterilize, reprocess, or reuse. Device is sterile if package is unopened or undamaged. Do not use the device
if there is doubt as to whether the package is sterile.
P015612-03 13APR21 (2021-04-13)
Turbo-Power™ Laser Atherectomy Catheter
Mean Standard Deviation
68.3 10.1
Number Percentage (%) (n=65) Percentage (%) (n=65)
39 60.0
11 16.9
49 75.4
5 7.7
42 64.6
16 37.2
26 60.5
26 40.0
57 87.7
55 84.6
7 10.8
Total (n=65)
60
5
Mean SD
4.9 0.8
56.0 47.2
77.1 15.7
42.5 13.2
21.1 14.5
Possibly Related Probably Related
to Investigational to Investigational
Device Device
0 0
0 1
0 0
Possibly Related Probably Related
to Investigational to Investigational
Device Device Device
0 0 0
0 2 0
5 0 0
3 0 0
9.2

Inspection Prior to Use

Before use, visually inspect the sterile package to ensure that seals have not been broken. The Turbo-Power System should be carefully examined for
defects (i.e. bends, kinks or other damage). Do not use if device is damaged. If the device is considered damaged; reference RETURN PRODUCT section
of this IFU.

10. COMPATIBILITY

The Spectranetics Laser Atherectomy Catheter is designed and intended to be used exclusively with the Spectranetics CVX-300™ Excimer Laser or the
Philips Laser System. Do not use in combination with any other laser system.
Some or all of the following additional materials, which are not included in the laser catheter package, may be required for the procedure
• 0.018" guide wires greater than 220cm in length
• 6F introducer sheaths (compatibility with Model # 420-050)
• 7F introducer sheaths (compatibility with Model # 423-050)
• 6F crossover sheaths (compatibility with Model # 420-050) (Crossover sheaths with metallic banded designs are NOT recommended.)
• 7F crossover sheaths (compatibility with Model # 423-050) (Crossover sheaths with metallic banded designs are NOT recommended.)
• Control syringe lled with sterile saline
• Pressurized infusion setup with sterile saline

11. DIRECTIONS FOR USE

The use of the laser system is restricted to physicians who are trained in peripheral vascular Intervention 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 Excimer Laser Ablation technique in occlusions that meet the indications for use.
4. A review of laser operation followed by a demonstration of the laser system.
5. Hands on training with the laser system and appropriate model.
6. A fully trained Spectranetics representative will be present to assist for a minimum of the rst three cases.
Following the formal training session, Spectranetics will make additional training available if requested by the physician, support personnel, the institution,
or Spectranetics.
11.1

Device Preparation

1. Using sterile technique, carefully remove the Turbo-Power System from sterile packaging. Remove the packaging lid from the packaging tray.
Remove the packaging wedges from the tray. Lift the proximal coupler located in the tray, and hand it outside the sterile eld to be inserted
into the laser system.
CAUTION: The proximal coupler of the laser catheter connects only to the laser system by means of a length of tail tubing, and is not intended to have
any patient contact.
2. Insert the proximal coupler of the laser catheter into the laser system and position a loop of the laser catheter tail tubing into the laser system
extension pole or catheter retainer.
3. Maintaining sterile technique, grasp the MDU from the middle of the packaging tray and remove the rest of the catheter system.
4. Prior to using the Turbo-Power System, carefully examine the device for any bends, kinks, or other damage. A slight curvature in the catheter
is normal due to packaging and will not impact device performance or safety.
CAUTION: Do not use the Turbo-Power System if any damage is observed. If the device is considered damaged; reference RETURN PRODUCT section of
this IFU.
5. Prior to calibration, ensure that the laser catheter distal tip is dry. A wet laser catheter tip may prevent successful device calibration.
6. Calibrate the laser catheter at 45 Fluence and 25 Hz and according to the instructions provided in the CVX-300™ Excimer Laser System
Operator's Manual or Philips Laser System Operator's Manual.
NOTE: The Turbo-Power System can be operated within 30-60 Fluence range and 25-80 Repetition Rate (Hz) in "Continuous On" mode for the Philips Laser
System with software version 1.0 (b5.0.3) or higher and for the CVX-300™ Excimer Laser System with software version V3.812 or higher.
NOTE: For CVX-300™ Laser System software versions V3.712 or lower, the maximum repetition rate is 40 Hz for the Turbo-Power System. Consult your
CVX-300™ Laser System to determine its operational version of software.
7. Remove the battery pull-tab from under the MDU and activate MDU power. Ensure the green power indicator light activates. Press "<"
rotation button and con rm tip rotation functionality. Press ">" rotation button and con rm tip rotation functionality. Press "<" and ">"
rotation buttons simultaneously and con rm tip rotation functionality.
NOTE: If at any point in the procedure the error light on the MDU activates, discontinue use of the device.
8. Flush the catheter guidewire lumen via the ush port located on the side of the MDU with sterile saline to ensure lumen patency.
9. Hydrate the outer surface of the Turbo-Power System to activate the hydrophilic coating by immersing the working length of the laser
catheter in a basin or by gently wiping the device with gauze saturated with sterile saline.
CAUTION: Do not dip or submerge the Motor Drive Unit.
11.2

General Operation

1. Use standard femoral puncture technique and insert a 6F or 7F introducer sheath into the common femoral artery in the antegrade or
retrograde fashion. Ensure patient is anticoagulated per current hospital interventional protocols.
2. Perform baseline angiography by injecting contrast medium through the introducer sheath or guiding catheter per standard technique.
Obtain images in multiple projections, delineating anatomical variations and morphology of the lesion(s) to be treated.
3. Introduce and advance a 0.018" guidewire through the treatment site via the introducer sheath or guiding catheter. In the presence of a wire
refractory obstruction or occlusion, refer to the Step-by-Step Method for a Total Occlusion below.
4. Con rm the reference vessel diameter is 3.0mm or greater prior to using the 6F Turbo-Power System. Con rm the reference vessel diameter
is 3.5mm or greater prior to using the 7F Turbo-Power System.
5. Advance the distal tip of Turbo-Power System over the proximal end of the 0.018" guidewire by threading the guidewire through the
eccentric lumen. After the guidewire is advanced through the laser catheter tip, continue advancing the guidewire through the Turbo-Power
System until it is accessible at the MDU's proximal end.
6. Under uoroscopic control, guide the Turbo-Power System to the lesion.
WARNING: Do not attempt to advance or retract the Turbo-Power System against resistance until cause of the resistance has been determined by
uoroscopy or other means. This may result in damage to the device and/or lead to complications such as dissections and/or perforations.
CAUTION: Do not force or excessively torque the Turbo-Power System as this may result in deformation of the distal tip or kinking of the device or result
in damage to the device and/or lead to complications.
7. Set up a saline infusion pressurized system according to the Saline Infusion Protocol below.
8. Inject contrast media through the introducer sheath or crossover sheath to verify the location of the laser catheter under uoroscopy.
9. Initiate saline ush via infusion pressurized system and clear the intended laser treatment eld of contrast media.
CAUTION: Ensure contrast media has been ushed from the intended treatment vessel according to the Saline Infusion Protocol below prior to
activating laser.
WARNING: Do not inject contrast media through the Turbo-Power System guidewire lumen as this may cause the system to lock-up and may lead to
further complications.
10. Under uoroscopic guidance, depress the footswitch of the laser system and SLOWLY (less than 1mm per second) advance the Turbo-Power
System into the stenosis, allowing the laser energy to photoablate the desired material.
Instructions for Use
English / English
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