CE Mark Approval Also in Place
Spectranetics Corporation (Nasdaq:SPNC) today reported 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.
