Healthcare Industry News:  anastomosis 

Devices Neurosurgery

 News Release - January 3, 2007

Spectranetics Laser System Used in Neurovascular Surgery for First Time in U.S.

COLORADO SPRINGS, Colo., Jan. 3 (HSMN NewsFeed) -- Spectranetics Corporation (Nasdaq: SPNC ) today announced that its excimer laser system was used during a neurovascular surgical procedure for the first time in the United States recently at Roosevelt Hospital in New York City. The surgical procedure was described in a New York Times article published December 19, 2006 (http://www.nytimes.com/2006/12/19/health/19brai.html?8dpc). The procedure incorporates a laser-assisted neurovascular surgery technique developed by Spectranetics' strategic partner, Elana BV of the Netherlands.

According to the New York Times, the procedure, which used the excimer laser to treat a giant aneurysm, is not approved in the United States, but permission was granted by the Food and Drug Administration on a compassionate use basis to Roosevelt Hospital. The Dutch neurosurgeon who devised the laser procedure, Dr. Cornelis Tulleken, flew in from the Netherlands to advise on the U.S. procedure. Dr. Tulleken has performed a similar operation on about 300 patients in Europe, said the Times.

The physician who conducted the surgery, Dr. David J. Langer, was quoted in the New York Times article as saying, "If it was me, my head, and there was a new device that would allow me to have this operation without occluding an artery, that's what I'd want."

"We're proud to be a partner with ELANA as they work towards commercializing this important, life-saving technique pioneered by Dr. Tulleken," stated John G. Schulte, Spectranetics' chief executive officer.

The procedure developed by Elana is the only known technique that enables surgeons to create a vascular bypass without occluding the recipient vessel, allowing continued blood supply during the procedure. To make the connection for the bypass graft (anastomosis), a platinum implant is attached to the outside wall of the recipient vessel. The end of the bypass graft then is stitched to the wall of the recipient vessel, using the implant as a guide. Next a laser catheter is inserted through the bypass graft to the wall of the recipient vessel, and laser ablation is used to create a hole in the artery wall; the laser catheter removes the disc, enabling blood flow to the recipient vessel.

Spectranetics and Elana BV announced their development agreements in October 2004. The agreements provide for Spectranetics to supply laser systems and to develop and supply laser catheters. A cross-licensing arrangement of certain of each company's intellectual property rights also is a part of the agreements.

About Spectranetics

Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. Its CVX-300 excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy, and the removal of problematic pacemaker and defibrillator leads. Nearly all of the company's FDA-approved and investigational applications have received Communautes Europeennes (CE) mark registration for marketing within Europe. In April 2004 Spectranetics obtained 510(k) clearance from the FDA for the laser-based treatment of patients suffering from total occlusions (blockages) in their leg arteries that are not crossable with a guide wire.


Source: Spectranetics

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