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Peripheral Vascular

Turbo Tandem® Laser Guide Catheter with Laser Atherectomy Catheter

Turbo-Tandem integrates proven Spectranetics technologies to ablate plaque above the knee, restoring blood flow to the lower extremities. Combining a laser guide catheter with an excimer laser atherectomy catheter, Turbo-Tandem offers physicians the ability to precisely target the lesion. The angled ramp allows for circumferential guidance and positioning of the laser catheter within the vessel, and the spring-loaded handle with variable settings greatly simplifies use of the device for repeated passes through the vessel.

Primary Product Features

Short-Tapered Distal Tip
– <4F outside diameter
– Easy passage through stenotic lesions
12 Degree Ramp
– Consistent positioning of laser catheter
– Precise targeting of lesion
Spring-Loaded Handle
– Quick and easy laser catheter advancement

Primary Product Benefits

Creates larger lumens
Debulks lesions composed of multiple morphologies
Maximum laser deflection

Indications

Indicated for atherectomy of infrainguinal arteries.

Contraindications

No known contraindications.

Warnings

Do not use without a guidewire, as vessel injury may result. Always advance and manipulate the Turbo-Tandem System under fluoroscopic guidance to confirm the location and orientation of the tip. Do not attempt to advance or retract the laser catheter against resistance until the reason for the resistance has been determined by fluoroscopy or other means. Confirm the laser catheter is in the retracted state when advancing or retracting the Turbo-Tandem System without lasing. Do not inject contrast media through the Turbo-Tandem System or guidewire lumen as this could cause the system to lock-up and may lead to complications.

Precautions

Read the CVX-300® Excimer Laser System Operator’s Manual thoroughly before operating the CVX-300 Excimer Laser System to ensure safe operation of the system. This catheter has been sterilized using Ethylene Oxide and is supplied STERILE. The device is designated and intended for SINGLE USE ONLY and cannot be re-sterilized and/or reused. During the procedure, appropriate anticoagulant and vasodilator therapy should be provided to the patient per the institution's interventional protocols. The proximal coupler of the laser catheter connects only to the CVX-300 Excimer Laser System and is not meant to have any patient contact. Do not use the Turbo-Tandem System if any damage is observed. Advancement, manipulation, withdrawal of the Turbo-Tandem System, and advancement, re-positioning or retraction of the laser catheter should always be performed under fluoroscopic guidance.

Please see complete Instructions for Use before using the Turbo-Tandem.