Spectranetics Receives FDA Clearance To Market Turbo-Tandem System

Written by Jaime Tera and Wire Reports

Thursday, 09 July 2009 03:38

Spectranetics Corporation (Nasdaq:SPNC) is reporting that it has received clearance from the Food and Drug Administration (FDA) to market the Turbo-Tandem™, a single-use, disposable device indicated for atherectomy of infrainguinal arteries. CE mark approval is also in place for marketing within the European Union and was received earlier this month.

The Turbo-Tandem System is comprised of two integrated devices, a 7 French laser guide catheter in combination with a 2.0mm excimer laser ablation catheter. The Turbo-Tandem is designed to perform atherectomy and ablation of plaque in arterial lesions above the knee, primarily within the superficial femoral and popliteal arteries, restoring blood flow to the lower extremities. The angled ramp at the tip of the guide catheter allows the physician circumferential guidance and positioning of the laser catheter within the vessel, and push-button control greatly simplifies use of the Turbo-Tandem for repeated passes through the vessel.

Emile J. Geisenheimer, Chairman, President and Chief Executive Officer, commented, “I am pleased to receive FDA clearance of the Turbo-Tandem system earlier than expected. Approximately two-thirds of all atherectomy procedures in the leg are performed above the knee and we look forward to targeting this important segment of the peripheral atherectomy market, which we believe is in excess of $150 million annually. We will debut the product this week at the New Cardiovascular Horizons meeting being held in New Orleans and will review our Turbo-Tandem launch plans with our entire United States sales organization at our mid-year meeting next week.”

About Spectranetics

Spectranetics manufactures and markets the only Excimer Laser System approved in the United States, Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system. More than 800 Spectranetics laser systems are used in hospitals worldwide.

The Company’s Vascular Intervention (VI) products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.

The Lead Management (LM) product line includes excimer laser sheaths and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads.

For more information visit www.spectranetics.com.

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