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The Turbo Elite devices are indicated for use in the treatment of infrainguinal stenosis and occlusions. When used in conjunction with the Turbo Booster and/or as an accessory to the Turbo Tandem System, the devices are indicated for atherectomy of infrainguinal arteries. The 0.014" and 0.018" Over-the-wire (OTW) Turbo Elite laser catheters are also indicated for use as an accessory to the use of the Turbo Tandem System in the treatment of femoropoplited artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Spectranetics Turbo Elite Laser Ablation Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen for Over-the-Wire (OTW) configurations, and bundled together for Rapid-Exchange (Rx) versions. Turbo Elite Laser Ablation Catheters are available in an Over the Wire (OTW) configuration and a Rapid Exchange (RX) configuration. The Turbo Elite laser catheters in the OTW configuration are available in six different catheter tip sizes (0.9mm, 1.4mm, 1.7mm, 2.0mm, 2.3mm, and 2.5mm) and three different guide-wire compatibilities (0.014", 0.018", and 0.035"). New indication clearance is only being requested for the OTW configurations of Turbo Elite catheters compatible with 0.014" and 0.018" quidewires. The Turbo-Tandem Laser Guide Catheter with Laser Atherectorny Catheter (Turbo-Tandem System) is a laser atherectomy catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser atherectomy catheter. The Turbo-Tandem System is designed to be used to directionally ablate infrainguinal concentric lesions in vessels 5mm or greater at or above the knee. The Turbo Tandem Laser Guide Catheter with Laser Atherectorny Catheter is available in two sizes; a 7F and 8F with a 2.0mm equivalent laser catheter embedded in the system. New indication clearance is only being requested for the Turbo-Tandem 7F catheters. The multifiber laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to an obstruction in the patient's artery. The ultraviolet energy is delivered to the tip of the laser catheter to photoablate fibrous, calcific, and atheromatous lesions, 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 LexiPliant™ Dilator Sheath Set is intended for use in patients requiring the percutaneous dilatation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects.

The LexiPliant Dilator Sheath Set family consists of an inner and outer polymer sheath that may be used individually or as a set in a telescoping fashion. The inner sheath terminates with beveled tips. The outer sheath terminates with one beveled tip and one blunt tip. The sheaths are designed to dilate tissue while facilitating the removal of cardiac leads, indwelling catheters and foreign objects. The device is introduced at a cardiac pacemaker or defibrillator pocket's implantation site and then advanced over the lead or object that is to be extracted. The rotation and progression of the inner and outer sheaths causes dilation of the tissue binding the lead or object within the vasculature. Upon dilation of the surrounding tissue, the lead or object can be removed by traction.