COLORADO SPRINGS, Colo., Sept. 18 /PRNewswire/ -- The Spectranetics Corporation (Nasdaq: SPNC) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to expand the clinical trial of the Spectranetics Laser Sheath (SLS). The laser sheath, specifically designed to assist in the removal of pacemaker and implantable cardioverter defibrillator (ICD) leads, was unanimously recommended for approval by an FDA advisory panel on July 29, 1997.
The FDA action allows expansion of the number of U.S. medical sites for the SLS trial to 50 from 35 and allows an additional 500 patients to be considered for the trial. The expansion allows the Company to introduce the SLS to sites which could previously remove leads only through non-laser techniques.
Annually, approximately 300,000 pacemaker and ICD leads are implanted worldwide. The Company estimates that 10% of these leads may require removal for medical reasons. Non-laser pacing/ICD lead removal techniques can be lengthy, surgical procedures carrying high risks to patients.
Spectranetics believes that the SLS, based on the Company's proprietary excimer laser technology, allows physicians to remove lead wires in a safe and efficacious manner. According to data presented to the FDA, the success rate for complete removal of leads with the Spectranetics technology was 94%, compared with 65% with non-laser techniques. Spectranetics received CE mark approval in March 1997 to distribute the SLS to European Union countries, and eight centers are currently trained.
Pacing and ICD leads are the conduit through which pacemakers and ICDs regulate the heartbeat with electrical pulses. Eventually, leads may become ineffective, requiring that new leads be implanted. Historically, the old leads have been left in place because they are often heavily embedded in scar tissue, making extraction traumatic and potentially dangerous. Abandoning leads may cause medical problems, such as thrombosis, or blockage, of blood flow; migration of broken leads in the vascular system, or the unavailability of veins for replacement leads to be implanted.
The Spectranetics excimer laser system is the only excimer laser market approved by FDA for cardiovascular procedures. The excimer laser dissolves tissue in a photo-ablative process, as opposed to burning tissue in a heat- intensive process. The CVX-300 excimer laser system has been designed for use in multiple cardiovascular applications, including crossing total occlusions and peripheral vascular angioplasty, as well as lead extraction and coronary angioplasty, the core application. There are approximately 200 CVX-300 systems installed worldwide.
Note: Spectranetics and CVX-300 are registered trademarks of The Spectranetics Corporation.
/CONTACT: James P. McCluskey, Vice President, Finance, or Jan Morton, Investor Relations, both for Spectranetics Corporation, 719-633-8333/ |
