Inhaltsverzeichnis; Device Description; Indications / Intended Use; Contraindications - Spectranetics Turbo-Power Gebrauchsanweisung

1. Device Description .................................................................................... 4
2. Indications / Intended Use ....................................................................... 4
3. Contraindications ..................................................................................... 4
4. Warnings .................................................................................................... 4
5. Precautions ................................................................................................ 5
6. Potential Adverse Events .......................................................................... 5
7. Clinical Studies .......................................................................................... 5
1.

DEVICE DESCRIPTION

The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300™ Excimer Laser System or the
Philips Laser System*.
The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used
exclusively with SPNC's CVX 300™ Excimer Laser System or the Philips Laser System and is a Type CF device De brillation proof.
Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment
of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used
to ablate infrainguinal concentric and eccentric lesions in vessels that are 3.0mm or greater in diameter.
The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser
shaft which connects the catheter ber optics to the laser system. See Figures 1, 2, 3, and 4. Table 1.1 contains a summary of dimensions and accessory
compatibilities for the device.
Radiopaque Tip
Working Length
Motor Drive Unit
Figure 1. Turbo-Power Laser Atherectomy Catheter
Error Indicator
Power Indicator
Power Button
Position LEDs
Rotation Buttons
Figure 2. Turbo-Power User Interface
Fiber Optics
Torque Wire
Guidewire Lumen
Figure 4. Turbo-Power Distal Tip Cross Section Table
Table 1.1: Turbo-Power (Model # 420-050 and 423-050) dimensions and compatibilities
Feature Model #: 420-050
Working length
Wire Compatibility
Sheath Compatibility
Laser Catheter 2.0mm Over The Wire
*Note: The Philips Laser System may not be available in all markets where the Turbo-Power Laser Atherectomy Catheter is sold.
P015612-03 13APR21 (2021-04-13)
Turbo-Power™ Laser Atherectomy Catheter
Guidewire Lumen
Tail Tube
Proximal Coupler
Pull Tab
Figure 3. Turbo-Power User Interface
Model #: 423-050
150cm 125cm
0.018" (0.46mm) 0.018" (0.46mm)
6F 7F
2.3mm Over The Wire
Table of Contents
8. Individualization of Treatment ................................................................ 7
9. How Supplied ............................................................................................ 7
10. Compatibility............................................................................................. 7
11. Directions for Use ..................................................................................... 7
12. Manufacturer's Limited Warranty ............................................................ 8
13. Non-Standard Symbology ........................................................................ 8
The working length of the Turbo-Power laser catheter is constructed of multiple optical bers arranged eccentrically around a 0.018" (0.46mm)
guidewire-compatible lumen. The guidewire lumen tip is attached to a torque wire which is connected to the MDU at the proximal end of the working
length. The MDU allows the user to rotate the torque wire by pressing each of the two rotation buttons individually or simultaneously on the MDU,
thereby directing the catheter tip. The position LEDs on the MDU indicate the rotation bias of the proximal end of the torque wire and motor position
within the range of allowed rotations in a given direction. The MDU can only be used to rotate the torque wire a limited number of turns in a single
direction, indicted by the progression of LEDs. The Home symbol associated with these LEDs indicates when the torque wire is in a neutral state.
The device incorporates a micro-processor with software. Software version identi cation is available to designated individuals with specialized tools and
training. The catheter ber optics are routed through the MDU and into the proximal laser shaft, terminating at the pin-coded coupler, which connects
the Turbo-Power device to the laser system. The outer surface of the laser catheter working length is hydrophilic-coated. The distal tip of the catheter
contains a radiopaque marker band for in situ visibility.
Mechanism of Action
The multi- ber laser catheter transmits ultraviolet energy from the laser system to the obstruction in the artery. The ultraviolet energy is delivered to
the tip of the laser catheter to photoablate multiple morphology lesions which may be comprised of atheroma, brosis, calcium, and thrombus, thus
recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal
damage to surrounding tissue.
Glossary of Special Terms
Retrograde Fashion = In the direction opposite to blood ow.
Antegrade Fashion = In the direction of blood ow.
Baseline Angiography = Angiographic record of blood vessels prior to intervention.
Contralateral Approach = Arterial access by a crossover approach.
2.

INDICATIONS / INTENDED USE

Turbo-Power is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal
artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).
3.

CONTRAINDICATIONS

No known contraindications.
4.

WARNINGS

• No modi cation of this equipment is allowed.
• Use of accessories, transducers and cables other than those provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• Reciprocal interference: use of this equipment adjacent to or stacked with other equipment should be avoided because it could result
in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are
operating normally.
• Do not use without a guidewire, as vessel injury may result.
• Do not activate laser until all contrast media is ushed from the treatment area.
• Always advance and manipulate the Turbo-Power System under uoroscopic guidance to con rm the location and orientation of the tip.
• Do not attempt to advance or retract the Turbo-Power System against resistance until the reason for 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..
• Do not inject contrast media through the Turbo-Power System or guidewire lumen as this could cause the system to lock-up and may lead
to complications.
• When used according to the "General Operation", avoid lasing and/or rotating the distal tip over the oppy/spring portion of the guidewire.
This may lead to complications such as dissections and/or perforations.
• This device is designated for use solely as a component of the Spectranetics CVX-300® Excimer Laser System or the Philips Laser System.
• Adequate instructions for the safe installation of the Spectranetics CVX-300® Excimer Laser System and Philips Laser System are provided in
servicing information provided by Spectranetics and should be followed.
• This equipment is suitable for use in a professional healthcare facility environment as described in ANSI/AAMI/IEC 60601-1-2:2014 Medical
Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests. Use of this equipment outside of this environment could result in improper operation.
• Do not use this device near active high frequency surgical equipment and the Radio Frequency shielded room of a Medical Electrical system
for magnetic resonance imaging, where the intensity of electromagnetic disturbances is high as this could result in improper operation.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer
than 30 cm (12 inches) to any part of the Turbo-Power System, including cables speci ed by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
• For the treatment of In-stent Restenosis (ISR), clinical data is not available on the following patient population and alternative therapies
should be considered for patients exhibiting the following angiographic criteria:
1. Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis ≥ 50% diameter stenosis that is not successfully treated prior
to index procedure (e.g. where a perforation occurred requiring a covered stent) or with nal residual stenosis ≥ 30% documented
by angiography.
2. Identi cation of any native vessel lesion (excludes in-stent restenosis) proximal to the target stent in the femoropopliteal segment
>50% that is not successfully treated prior to index procedure (e.g. complication requiring additional treatment) or with nal
residual stenosis ≥ 30% documented by angiography. The lesion length must be treatable with a single stent (if required). The lesion
must not be contiguous with the target lesion; at least 2 cm of normal appearing vessel between the lesion and target lesion/ target
stent or between deployed stent (if required) and the target lesion/ target.
3. Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up
(including, but not limited to aortic, renal, cardiac, carotid, contralateral femoropopliteal, and contralateral below the knee).
4. Identi cation of any lesion distal to the stent >50% that will require preplanned or predicted treatment during the index procedure or
within 30 days of the index procedure.
5. Grade 4 or 5 stent fracture a ecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen
is noted on angiography in two orthogonal views. Stent integrity may be characterized according to the following scale:
Instructions for Use
Table 4.1: Stent Integrity Categories
Grade Description
0 No strut fracture
I Single tine fracture
II Multiple tine fracture
III Stent fracture(s) with preserved alignment of the components
IV Stent fracture(s) with mal-alignment of the components
V Stent fracture(s) in a trans-axial spiral con guration
English / English
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