FDA Clears Spectranetics Turbo-Tandem Atherectomy System
July 10, 2009 – Spectranetics Corp. said today it received FDA-clearance 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 mm 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.
Approximately two-thirds of all atherectomy procedures in the leg are performed above the knee. The company said the device helps it enter the peripheral atherectomy market, which is estimated to include total sales in excess of $150 million annually.
For more information visit www.spectranetics.com