FDA Approves Spectranetics' 0.9 MM Catheter

COLORADO SPRINGS, Colo., Aug. 16 -- The Spectranetics Corp. has received the approval of the US Food and Drug Administration to market the Vitesse 0.9-mm rapid exchange disposable catheter in the US. This catheter is used to help repair blood vessels in the heart by delivering excimer laser energy to burn up plaque that is limiting blood flow within coronary arteries as small as 1.5 mm in diameter.
This is an important approval for us, said Joseph A. Largey, CEO of Spectranetics. There are more than 800,000 angioplasty procedures performed in the United States every year, and more than 1.3 million worldwide. One of our constraints in the marketplace has been our inability to offer a small catheter.