Spectranetics Corporation announced the presentation of results from its Cello (CLiRpath Excimer Laser System to Enlarge Lumen Openings) clinical trial, at the nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
The study was a prospective, non-randomised trial designed to provide clinical data on the reduction of arterial blockage in above-the-knee arteries following use of the Spectranetics TURBO-Booster product for the treatment of peripheral artery disease (PAD). TURBO-Booster received clearance from the Food and Drug Administration (FDA) in July 2007 following the conclusion of the trial, which enrolled 65 patients at 17 hospitals in the United States.
"The six-month data from the Cello trial demonstrates the ability of laser ablation facilitated by the TURBO-Booster to safely restore blood flow in the superficial femoral artery and significantly improve clinical outcomes in patients with peripheral arterial disease up to six months following the procedure. Many patients suffer unnecessarily from pain in the legs and feet that can drastically impact active lifestyles. The TURBO-Booster represents a viable treatment option for those patients with peripheral arterial disease," said Dr. Rajesh Dave, chairman and national principal investigator of the CELLO trial, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital.
Spectranetics TURBO-Booster functions as a guiding catheter facilitating directed ablation of blockages in the main arteries at or above the knee. The TURBO-Booster combined with Spectranetics' Turbo elite laser catheters allows for removal of large amounts of plaque material within the superficial femoral artery (SFA) and popliteal arteries.
"With conclusive data on the effectiveness of the TURBO-Booster product, Spectranetics is working with physicians to improve the lives of the millions suffering from blocked arteries above the knee. Our laser ablation system is easy to use and effective at getting patients back on their feet and engaged in active lifestyles. Since receiving FDA clearance in July, several hundred procedures have been performed, with more than 180 accounts placing their initial order and nearly 45 per cent of those having already re-ordered. Our limited market release of TURBO-Booster is right on schedule and we plan to complete this initial phase of our market launch in the current quarter., " said John G. Schulte, president and CEO, Spectranetics.
Founded in 1984, Spectranetics manufactures and sells the only excimer laser approved in the United States, Europe and Japan for use in minimally invasive cardiovascular procedures. This technology treats complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the blood stream. The company's disposable catheters use high-energy "cool" ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads.