Spectranetics Surpasses Endpoint for PAD in CELLO Trial
October 24, 2007 - Spectranetics Corp. announced at TCT 2007 that its CELLO (CLiRpath Excimer Laser System to Enlarge Lumen Openings) clinical trial exceeded the targeted primary endpoint by achieving significant tissue removal and demonstrating the ability of laser ablation facilitated by the TURBO-Booster to restore blood flow in the superficial femoral artery.
The 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 laser catheters allows for removal of large amounts of plaque material within the superficial femoral artery (SFA) and popliteal arteries.
The study was a prospective, non-randomized 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).
Highlights of the data presented include:
- Achievement of significant tissue removal, which exceeded the targeted primary endpoint, measured by angiographic and IVUS core labs;
- Demonstrated durability of procedure through freedom from target lesion revascularization in 86 percent of the patients through six months following the initial procedure;
- No major adverse cardiac events reported through six months following the procedure, which adds to the existing body of clinical evidence supporting the safety of laser ablation; and
- Significant improvement in all clinical outcomes measured six months following the procedure, including Rutherford category, ankle-brachial Index and walking impairment.
“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,” said Rajesh Dave, M.D., national principal investigator of the CELLO trial and chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital.
For more information: www.spectranetics.com