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Spectranetics
Download PDF Members: Spectranetics manufactures and sells the only excimer laser approved in the United States, Europe and Japan for use in multiple, minimally invasive cardiovascular procedures. This technology treats complex cardiovascular conditions by vaporizing lipid-based, calcified and fibrotic plaque, saphenous vein graft disease, and neointimal hyperplasia. Excimer laser is also used to remove scar tissue holding problematic pacemaker and defibrillator cardiac leads in place. The Company’s disposable catheters use high-energy “cool” ultraviolet light to vaporize blockages into tiny particles that are easily absorbed into the blood stream, reducing complications and improving clinical outcomes. Excimer Laser Ablation System Over 600 laser ablation systems are installed worldwide, with nearly 500 in the United States. Catheter Products Spectranetics’ offers laser ablation for peripheral intervention, coronary intervention, and lead removal (ablating the scar tissue holding problematic pacemaker and defibrillator leads in place) Peripheral Intervention: TURBO elite™ laser ablation catheters Coronary Intervention: ELCA® laser ablation catheters Lead Removal: SLS ® II laser ablation catheter Crossing Devices: Quick-Cross® support catheters Clinical Trials On March 14, 2007 enrollment was completed in the FDA-approved CELLO Trial. The trial was designed to provide clinical data on the reduction of arterial blockages in above the knee arteries following the use of our TURBO-Booster™ product, a non-laser based product used in conjunction with TURBO elite laser ablation catheters. The TURBO-Booster product is designed to facilitate laser ablation of larger diameter arteries above the knee. We believe that approximately two-thirds of the estimated 400,000 endovascular procedures performed annually in the U.S. are performed on above the knee blockages. The CELLO Trial data will be gathered and the 510(k) application is currently expected to be filed with the FDA in Q2 2007. History Spectranetics was founded in 1984 by Robert Golobic, Ph.D., a United States Air Force physicist and Johan Sverdrup, a Hewlett-Packard engineer. Golobic had been working on lasers as part of the Strategic Defense initiative and Sverdrup had done ultrasound work with ADR (Advanced Diagnostic Research) and Doppler imaging with Vingmed. Together they created Spectranetics – one of the first companies in the world to explore the possibility of using a “cool” ultraviolet laser to clear occluded arteries. The first patient was treated at the Texas Heart Institute in 1989.
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