Spectranetics P017734-00 Turbo-Elite Laser Atherectomy Catheter Instructions

Instructions for Use
for OTW and RX Catheter Models

P017734-00 16FEB21 (2021-02-16)

Description

Spectranetics Turbo-Elite Laser Atherectomy Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen. Catheter sizing identification is printed on the catheter.

For Turbo-Elite Laser Atherectomy Catheter, Over-The-Wire (OTW) catheters, a luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriate sized guidewire (0.014″, 0.018″, and 0.035″); see inset below.
For Turbo-Elite Laser Atherectomy Catheter, Rapid Exchange (RX) catheters, the guidewire lumen is formed only through the last 9 cm of the distal tip, which has direct patient contact, and is concentric with the fiber array; see inset below.

Mechanism of Action for Turbo-Elite Laser Atherectomy Catheters
The multifiber laser catheters transmit ultraviolet energy from the Spectranetics CVX-300 Excimer Laser to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photoablate lesions which may be comprised of atheroma, fibrosis, 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). The Spectranetics laser catheters have a proprietary lubricious coating to ease their trackability through arteries.

Glossary of Special Terms
Retrograde Fashion = In the direction opposite to blood flow.
Antegrade Fashion = In the direction of blood flow.
Baseline Angiography = Angiographic record of blood vessels.
Contralateral Approach = Arterial access by a crossover approach.

Figure 1: Turbo-Elite Laser Atherectomy Catheter (OTW)

Table 1.1 Turbo-Elite Laser Atherectomy Catheter OTW Models

Device
Description| Model
Number| Guidewire
Compatibility
(in.)| Max. Tip
Diameter
(in.)| Max. Shaft
Diameter
(in.)| Working
Length
(cm)| Sheath
Compatibility
(Fr.)
---|---|---|---|---|---|---
Over-The-Wire (OTW) Catheter Specifications
0.9 mm| 410-152| 0.014| 0.038| 0.047| 150| 4
1.4 mm| 414-151| 0.014| 0.055| 0.056| 150| 5
1.7 mm| 417-152| 0.018| 0.068| 0.069| 150| 5
2.0 mm| 420-006| 0.018| 0.080| 0.081| 150| 6
2.3 mm| 423-001| 0.018| 0.091| 0.091| 125| 7
2.5 mm| 425-011| 0.018| 0.101| 0.102| 112| 8
2.3 mm| 423-135-02| 0.035| 0.091| 0.091| 125| 7
2.5 mm| 425-135-02| 0.035| 0.101| 0.102| 112| 8

Figure 2: Turbo-Elite Laser Atherectomy Catheter (RX)

Table 1.2 Turbo-Elite Laser Atherectomy Catheter RX Models

Device
Description| Model
Number| Guidewire
Compatibility
(in.)| Max. Tip
Diameter
(in.)| Max. Shaft
Diameter
(in.)| Working
Length
(cm)| Sheath Compatibility (Fr.)
---|---|---|---|---|---|---
Rapid Exchange (RX) Catheter Specifications
0.9 mm| 410-154| 0.014| 0.038| 0.049| 150| 4
1.4 mm| 414-159| 0.014| 0.057| 0.062| 150| 5
1.7 mm| 417-156| 0.014| 0.069| 0.072| 150| 6
2.0 mm| 420-159| 0.014| 0.080| 0.084| 150| 7

Indications for Use

For atherectomy of infrainguinal arteries.

Contraindications

No known contraindications.

Warnings

Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training.
Spectranetics’ Turbo-Elite Laser Atherectomy Catheters CVX-300 Excimer Laser software requirements:

When the laser catheter is in the body, it should be manipulated only while it is under fluoroscopic observation with radiographic equipment that provides high quality images.
The laser catheter should not be operated in the presence of contrast. Prior to use, flush all residual contrast media from the introducer sheath or guide catheter and in-line connectors. For the 1.4-2.0 RX design, failure to do so may result in damage or dislodgement of the tip. Saline must be infused throughout the entire lasing process.

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 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 specific requirements relating to hospital waste, and potentially biohazardous materials.

Read the Operator’s Manual thoroughly before operating the CVX-300 Excimer Laser. 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 vasodilator therapy should be provided to the patient per the institution’s protocol.

Saline must be infused throughout the entire lasing process.

Adverse Events

Use of the Spectranetics Turbo-Elite in conjunction with the CVX-300 Excimer Laser may contribute to the following complications:

Events Observed during Clinical Studies (see Section 7)

Procedural Complications| Serious Adverse Events| In-Hospital Complications
---|---|---
• Spasm
• Major dissection
• Thrombus
• Distal embolization
• Perforation
• Other| • Death
• Reintervention
• ALI
• Major amputation
• Bypass surgery
• Hematoma with surgery| • Re-occlusion
• Pseudoaneurysm
• Renal failure
• Bleeding

Potential Adverse Events NOT Observed during Clinical Studies (see Section 7)

• Nerve injury
• Stroke
• AV fistula formation
• Myocardial infarction
• Endarterectomy
• Arrhythmia
• Infection

No long-term adverse effects on the arterial vessel wall, due to peripheral excimer laser recanalization, are known at this time.

Clinical Studies

CELLO Study
Data presented in this IFU were collected in support of safety and efficacy for Spectranetics brand TURBO-Booster and CLiRpath TURBO catheters. The CELLO (CLiRpath Excimer Laser System to Enlarge Lumen Openings) Study, IDE #G060015, enrolled 16 training cases and 45 analysis patients at 16 sites.

Efficacy: The primary efficacy 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 (34 percent in training cohort) using the TURBO-Booster system compared to pre-procedure in the study. The secondary efficacy endpoint for acute procedural success (visual assessment of final residual stenosis) was achieved in 97.8 and 100.0 percent of patients as visually assessed by physician in the enrolled and training cohort, respectively.

Table 7.1. Lesion Locations

Location of vascular lesions| Training (n=16)| Analysis (n=45)| Total (n=61)
---|---|---|---
SFA| 13| 43| 56
Popliteal| 3| 2| 5

Table 7.2 Procedural Information

Angiographic Results| Training (n=16)| Analysis (n=45)| Total (n=61)
---|---|---|---
Reference vessel diameter (mm)| 5.19| 4.79| 4.89
Average lesion length (mm)| 72.08| 50.89| 56.45
Percent diameter stenosis – Pre| 78.30| 77.3| 77.6
Percent diameter stenosis – After Turbo-Booster use| 44.0| 42.4| 42.8
Percent diameter stenosis – Final| 25.6| 20.9| 22.1

Table 7.3 Number of Occlusions Requiring Step-by-Step During Pilot Channel Creation

Total Occlusions Enrolled| Training n (%) Total| Analysis n (%)| n (%)
---|---|---|---
Total Occlusions – 100% Diameter Stenosis| 4 (25.0)| 9 (20.0)| 13 (21.3)
Step-by-Step Technique Used by Physician| 0 (0.0)| 1 (11.1)| 1 (1.6)
All Patients whereby step-by-step was not used during pilot channel creation| 16 (100.0)| 44 (97.8)| 60 (98.3)

In one out of the 61 patients (1.6%), the physician elected to use the step- by-step technique.

Table 7.4 Complications possibly related to the TURBO-Booster

Procedural Complications| Training (n=16)| Analysis (n=45)| Total (n=61)
---|---|---|---
Major dissection (Grade E or F)| 0| 0| 0 (0%)
Distal embolization| 1| 2| 3 (5%)
Other (Discomfort in treated leg post-procedure)| 0| 3| 3 (5%)

Safety: The primary safety endpoint measured was the occurrence of major adverse events, defined 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 first) at 30 days, and six (6) months. The CELLO study had no major adverse events reported. Additionally, there were no Serious Adverse Events or Unanticipated Adverse Device Effects.

CLI Studies
This data was based off previous versions of peripheral excimer laser atherectomy catheters. Data presented in this IFU are comprised of a subset of patients pooled from three sources of consecutively treated patients presenting with Critical Limb Ischemia (CLI), who were poor surgical candidates:

NOTE: All values based on angiographic core laboratory analysis

• LACI Phase 2 ­ a subset of patients from a prospective IDE registry conducted in 2001-2002 at 14 sites in the US and Germany. The subset includes 26 limbs (in 25 patients) treated at 7 sites from the US and Germany in which the step-by-step laser recanalization technique was utilized. In 13 of these cases, step-by-step technique was utilized ab initio, that is, without first attempting to cross the occlusion with a guidewire.
• LACI Belgium – a subset of a 51-patient prospective registry conducted at 6 sites in Belgium. The subset includes 9 limbs (in 9 patients) treated at 3 sites in Belgium in which the step-by-step laser recanalization technique was utilized.
• Louisiana case series ­ a subset drawn from 62 cases included in an on-going data compilation by a single physician group in central Louisiana, the Cardiovascular Institute of the South (CIS). This subset of patients consists of 12 limbs (in 12 patients) in which the step-by-step laser recanalization technique was utilized.

Table 7.5 Procedure Information

Locations of vascular lesions (n=205)

SFA| 138 (67%)
Popliteal| 23 (11%)
Infrapopliteal| 42 (20%)
Angiographic Results (n=47 limbs)
Lesions per limb| 4.
Average lesion length| 73.4 ± 7.3 (mm)
Straightline flow to foot established| 37 (79%)
Stent implanted| 28 (60%)
Crossing Success Overall*| 37 (79%)
Crossing success after guidewire attempt| 24/34 (71%)
Crossing success ab initio cases| 13/13 (100%)
Procedure success**| 34 (72%)

NOTE: 47 limbs in 46 patients were treated. All percent calculations are based on 47 limbs.

*Crossing Success data has been stratified for step-by-step cases after conventional guidewire attempts in 24 limbs, and ab initio in 13 limbs.
**Procedure success: 50% final residual stenosis

Table 7.6 Complications, n=47 limbs

Procedural Complications

Spasm| 1 (2%)
Major dissection| 4 (9%)
Thrombus| 1 (2%)
Distal embolization| 3 (6%)
Perforation| 3 (6%)
Other| 5 (11%)
In-Hospital Complications
Reocclusion| 1 (2%)
Pseudoaneurysm| 1 (2%)
Renal failure| 1 (2%)
Bleeding| 1 (2%)
Infection| 0 (0%)
Other| 0 (0%)

NOTE: 47 limbs in 46 patients were treated. All percent calculations are based on 47 limbs.

Table 7.7 Cumulative Serious Adverse Events (SAEs) through 6-month follow- up, for n=47 limbs

NOTE: 47 limbs in 46 patients were treated. All percent calculations are based on 47 limbs. MI = Myocardial Infarction. ALI = Acute Limb Ischemia.

Table 7.8 Outcomes by Intention-to-Treat Analysis, n=47

NOTE: 47 limbs in 46 patients were treated. All percent calculations are based on 47 limbs.

Individualization of Treatment

The risks and benefits described above should be carefully considered for each patient before use of the TurboElite Laser Atherectomy Catheter device.

Use of Turbo-Elite devices may be considered after initial conventional crossing attempts with guidewires are unsuccessful due to:

• A rounded or eccentric occlusion stump deflecting the guidewire to a subintimal passage.
• The guidewire repeatedly being deflected into a large collateral branch flush with the occlusion stump.
• Calcification obstructing completion of guidewire passage within the obstructed lumen. Additionally, recanalization of native arteries may be considered in patients presenting with occluded bypass grafts.

Patient selection and clinical techniques should be conducted according to instructions provided in Section 2, “Indications for Use,” and Section 9, “Operator’s Manual.”

Operator’s Manual

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

Table 9.1 Energy Parameters

Device Description| 1 Model No.| Fluence| Repetition Rate| Laser On / Off Time
---|---|---|---|---
OTW Catheters
0.9 mm| 410-152| 30-80| 25-80| Continuous On
1.4 mm| 414-151| 30-60| 25-80| Continuous On
1.7 mm| 417-152| 30-60| 25-80| Continuous On
2.0 mm| 420-006| 30-60| 25-80| Continuous On
2.3 mm| 423-001| 30-60| 25-80| Continuous On
2.5 mm| 425-011| 30-45| 25-80| Continuous On
2.3 mm| 423-135-02| 30-60| 25-80| Continuous On
2.5 mm| 425-135-02| 30-60| 25-80| Continuous On
RX Catheters
0.9 mm| 410-154| 30-80| 25-80| Continuous On
1.4 mm| 414-159| 30-60| 25-80| Continuous On
1.7 mm| 417-156| 30-60| 25-80| Continuous On
2.0 mm| 420-159| 30-60| 25-80| Continuous On

Recommended calibration settings: 45 Fluence, 25 Hz.

• 80 Hz maximum repetition rate is for software V3.8XX. For software V3.7XX, the maximum repetition rate is 40 Hz.

How Supplied

Sterilization

For single use only. Do not re-sterilize and/or reuse.

This device has been sterilized using Ethylene Oxide and is supplied STERILE. Sterility is guaranteed only if the package is unopened and undamaged.

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).

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.

Compatibility

• The Spectranetics laser Atherectomy catheter is designed and intended to be used exclusively with the Spectranetics CVX-300 Excimer Laser.
• Do not use in combination with any other laser system.
• Guidewire Compatibility
• See Catheter Specification Table in Section 1.

Directions for Use

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):

• Introducer sheaths and/or femoral guiding catheter(s) in the appropriate size and configuration to select the peripheral artery and facilitate largest laser catheter to be used.
• Tuohy-Borst “y” adapter or hemostatic valve(s).
• Sterile normal saline.
• Standard contrast media.
• 0.014″, 0.018″, and 0.035″ guidewires.

The use of the CVX-300 Excimer Laser 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 films 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 CVX-300 Excimer Laser.
5. Hands on training with the CVX-300 Excimer Laser and appropriate model.
6. A fully trained Spectranetics representative will be present to assist for a minimum of the first three 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.

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 CVX300 Excimer Laser, and is not meant to have any patient contact.

Connect the proximal end of the laser catheter to the CVX-300 Excimer Laser and position the laser catheter in the laser system extension pole. Calibrate the laser catheter following the instructions provided in the CVX-300 Excimer Laser Operator’s Manual.

• Use standard femoral puncture technique to insert a 4 Fr. to 9 Fr. (depending on the largest interventional device to be used during treatment) introducer sheath into the common femoral artery in antegrade or retrograde fashion for contralateral approaches. Heparinize intravenously using the protocol for heparinization.

• Perform baseline angiography by injecting contrast medium through the introducer sheath or guiding catheter. Obtain images in multiple projections, delineating anatomical variations and morphology of the lesion(s) to be treated.

• Introduce a 0.014″, 0.018″, or 0.035″ guidewire to the peripheral occlusion via the introducer sheath or guiding catheter.

• Size and choose the laser catheter appropriately:
  Table 12.1 Recommended Sizing
  ** Catheter Size| Proximal Vessel Diameter**
  ---|---
  0.9 mm| ≥1.4 mm
  1.4 mm| ≥2.1 mm
  1.7 mm| ≥2.6 mm
  2.0 mm| ≥3.0 mm
  2.3 mm| ≥3.5 mm
  2.5 mm| ≥3.8 mm

• Hydrate the outer jacket of the catheter to activate the hydrophilic coating. Either dip the catheter in a basin or wipe with wet gauze using an appropriate sterile solution.

• Flush the quidewire lumen of the laser catheter using 5-10 mL of heparinized saline.

• Introduce the distal tip of The Spectranetics laser catheter over the selected guidewire. Under fluoroscopic control, guide the laser catheter to the lesion. The laser catheter’s radiopaque band marker indicates its position relative to the lesion.
  Note: Always monitor laser catheter movement and the radiopaque tip marker position with fluoroscopy. 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.
  In the absence of apparent catheter movement, care should be taken not to deliver excessive laser energy.

• Inject contrast medium solution through the introducer sheath or guiding catheter to verify the positioning of the laser catheter under fluoroscopy.

• Following confirmation that the laser catheter’s position is in contact with the target lesion, and using normal saline solution:
  a. Flush all residual contrast media from the introducer sheath or 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. Warning: Do not activate the laser in the presence of contrast.
  c. Please refer to the Saline Infusion Protocol section of the Instructions for Use and perform saline flush and infusion per the instructions.

• When using Turbo-Elite Laser Atherectomy Catheter models, the CVX-300 Excimer Laser will continuously deliver energy as long as the footswitch is depressed. The length of the laser train is controlled by the operator. It is generally recommended not to exceed 20 seconds of continuous lasing.

• Step-by-Step Method for Total Occlusion
  a. Depress the footswitch, activating the CVX-300 Excimer Laser, and slowly, less than 1 mm per second, advance the laser catheter 2­3 mm into the total occlusion, allowing the laser energy to remove the desired material. Release the footswitch to deactivate the CVX-300 Excimer Laser.
  Note: Advancing the laser catheter through moderately calcified lesions may require more pulses of laser energy than fibrous atherosclerotic tissue
  b. Advance the guidewire beyond the distal tip of the laser catheter further into the occlusion, a few millimeters, and reactivate the laser as described in Step a above.
  c. Continue in this step-by-step manner where the guidewire and then the laser catheter are advanced and activated (mm by mm) until the catheter reaches the last 3-5 mm of the occlusion.
  d. Cross the last 3-5 mm of the occlusion and enter the patent distal vessel with the guidewire first, followed by the activated laser catheter over-the- wire.
  e. Leaving the guidewire in position, pull back the laser catheter and inject contrast medium through the guiding catheter and examine the lesion via fluoroscopy.
  f. Additional laser passes may be performed over-the-wire to achieve greater debulking of the lesion
  g. If resistance to catheter advancement is met (such as calcium), immediately stop lasing by releasing the footswitch to deactivate the CVX-300 Excimer Laser. The fluence and repetition rates can be increased in order to advance. To avoid the potential of heat build-up, the catheter must be advanced while lasing.
  Note: If the laser catheter is removed from the vessel for any reason, thoroughly clean the laser catheter’s outer surface, inner lumen, and tip with heparinized saline to prevent blood from sticking. Blood remaining on the laser catheter may diminish the efficiency of the laser catheter.

• Standard Method for Treating Stenoses
  a. Depress the footswitch, activating the CVX-300 Excimer Laser, and slowly, less than 1 mm per second, advance the laser catheter through the stenosis. Release the footswitch to deactivate the CVX-300 Excimer Laser.
  b. Additional laser passes may be performed over-the-wire to achieve greater debulking of the lesion. If resistance to catheter advancement is met (such as calcium), immediately stop lasing by releasing the footswitch to deactivate the CVX-300 Excimer Laser. The fluence and repetition rates can be increased in order to advance. To avoid the potential of heat build-up, the catheter must be advanced while lasing.

• There is no need to remove the laser catheter from the patient in order to increase or decrease either the fluence or pulse repetition rate; as the laser catheter was previously calibrated. Refer to the CVX-300 Excimer Laser Operator’s Manual.
  Caution: All patients should be monitored for blood pressure and heart rate during the procedure.

• Following laser recanalization, perform follow-up angiography and balloon angioplasty if needed. Stenting may be performed as required, in instances of acute recoil, major perforation, etc.

• Perform saline infusion protocol as required.
  Note : Use of two operators is recommended for this technique. 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 fluoroscopy pedal.
  a. Before the laser procedure, obtain a 500 mL bag of 0.9% normal saline (NaCl). It is not necessary to add heparin or potassium to the saline solution. Connect the bag of saline to a sterile intravenous line and terminate the line at a port on a triple manifold.
  b. If applicable, cannulate the ostium of the artery with an appropriate “large lumen” guide catheter in the usual fashion. It is recommended that the guide catheter not have side holes.
  c. Under fluoroscopic 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 flow and contrast removal while flushing 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.
  e. Remove the original control syringe from the manifold and replace it with a fresh 20 mL luer-lock control syringe. This new 20 mL control syringe should be primed with saline prior to connection to reduce the chance for introducing air bubbles. (Merit Medical and other vendors manufacture 20 mL control syringes.)
  f. Flush all traces of blood and contrast from the manifold, connector tubing, y-connector, and introducer sheath or guide catheter, with at least 20-30 mL of saline (several syringes of saline). When this initial flushing is completed, refill the 20 mL control syringe with saline.
  g. Under fluoroscopy, confirm 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 off to pressure and inject 10 mL of saline as rapidly as possible (within 1-2 seconds). This bolus injection is to displace and/or dilute blood down to the level of the capillaries and limit back-bleeding of blood into the laser ablation field.
  i. After the injection of the initial 10 mL bolus and without stopping the motion of injection, the scrub assistant should next slow down the rate of injection to minimum of 2-3 mL/second through a combination of the guidewire lumen and/or sheath.This portion of the saline infusion is to displace and/or dilute the antegrade blood flow entering the laser ablation field. At the instant the scrub assistant slows down the injection rate, the primary operator should activate the CVX-300 Excimer Laser by depressing the foot pedal and begin a lasing sequence.
  j. The length of the laser train is controlled by the operator. It is generally recommended not to exceed 20 seconds of continuous lasing. Saline must be infused throughout the entire lasing process.
  k. Terminate the saline injection at the end of the lasing train. Turn the manifold stopcock back to pressure and refill the control syringe with 20 mL of saline in preparation for the next lasing 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 d-g prior to reactivation of the CVX-300 Excimer Laser (before activating the laser repeat steps h-k).

Note: Depending on which approach is used, antegrade or contralateral, saline can be administered through the sheath (antegrade approach) or laser catheter inner lumen (contralateral approach). When the contralateral approach is used, smaller diameter guidewires are suggested to allow adequate saline infusion at the treatment site.

Warranty Information

Manufacturer warrants that the Turbo-Elite Laser Atherectomy Catheter is free from defects in material and workmanship when used by the stated”Use By”date and when package is unopened and undamaged immediately before use. Manufacturer’s liability under this warranty is limited to replacement or refund of the purchase price of any defective Turbo-Elite Laser Atherectomy Catheter. Manufacturer will not be liable for any incidental, special, or consequential damages resulting from use of the Turbo-Elite Laser Atherectomy Catheter. Damage to the Turbo-Elite 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 Manufacturer. This limited warranty covers only the Turbo- Elite Laser Atherectomy Catheter. Information on Manufacturer’s warranty relating to the CVX-300 Excimer Laser can be found in the documentation relating to that device.

Non-Standard Symbology

Max. Tip Diameter| | Max. Shaft Diameter|
---|---|---|---
Working Length| | Sheath Compatibility|
Guidewire Compatibility| | Energy Range|
Hydrophilic Coating| | Quantity|
Importer|
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.|

Applicable Standards

The standards identified in Table 15.1 were applied to the development of the device.
Table 15.1: Standards applied to the development of the Turbo-Elite.

Blocompatlblllty:
ISO 10993-1| I 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:
150 14644-1| Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness.
ISO 14644-2| Cleanrooms and associated controlled environments – Part 2: Specification 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
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
Duality:
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

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.

www.spectranetics.com

Spectranetics Corporation
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Tel: 1-800-231-0978 · Fax: 719-447-2022

Authorized Russian Representative:
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123022, Russia PHILIPS Limited Liability Company cmo-rca@philips.com

Contacts of the Attorney:
(Tel: (495) 937 93 00 Fax: (495) 937-93-07)

2021 Spectranetics Corporation

References

• Spectranetics | Philips

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