COLORADO SPRINGS, Colo., Sept. 19/ -- Spectranetics Corporation (NASDAQ:SPNC) today announced it will extend features of the recently launched 2.5 Turbo product to its entire CLiRpath(R) product line used for clearing arterial blockages in the leg. Spectranetics has received 510(k) clearance from the Food and Drug Administration for the "continuous on" lasing train to be added to its entire CliRpath product line.
"The initial physician feedback on both continuous on lasing and the hydrophilic coating incorporated into our 2.5 Turbo product has been extremely positive. These additions enable shortened procedure times and better tracking through tortuous anatomies," stated John G. Schulte, Spectranetics president and chief executive officer. "I'm particularly pleased with the fast FDA response, which came within 11 days of our 510k submission. Additional product improvements, including higher laser energy parameters and improved ablation efficiencies will be incorporated into the CliRpath product line during the first half of 2006, depending on FDA review cycles."
Spectranetics plans to launch the expanded CliRpath Turbo product line within the next 90 days, allowing for required software upgrades to be completed for its customers.
Many patients suffering from peripheral vascular disease and critical limb ischemia have total occlusions that cannot be crossed with standard guide wires, and have so few treatment options that surgery -- either bypass or limb amputation -- is nearly inevitable. CLiRpath (Cool Laser Revascularization for Peripheral Artery Therapy) provides an alternative in the fight against amputation.
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(R) 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.
Spectranetics, CVX-300, and CLiRpath are registered trademarks of The Spectranetics Corporation.
CONTACT: Guy Childs, Chief Financial Officer of Spectranetics Corporation, +1-719-633-8333
Web site: http://www.lhai.com/
Web site: http://www.spectranetics.com/