Spectranetics Corporation announced that it has received US FDA clearance to market its Turbo-Tandem. The Turbo-Tandem is a single-use, disposable device for atherectomy of infrainguinal arteries. It also received CE mark approval for marketing within the European Union 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. It 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 US sales organization at our mid-year meeting next week.”