FDA Clears Spectranetics to Market TURBO-Booster
July 5, 2007 – The FDA has cleared Spectranetics Corp. to market its TURBO-Booster product for the treatment of arterial stenoses and occlusions in the leg, a peripheral laser catheter that functions as a guiding catheter facilitating directed ablation of blockages in the main arteries at or above the knee.
The TURBO-Booster combined with Turbo elite laser catheters reportedly allows for removal of large amounts of plaque material within the SFA and popliteal arteries. The CELLO trial, the study conducted to provide data to FDA in support
of the 510(k) premarket notifications for the TURBO-Booster clearance, is a prospective registry that enrolled 61 patients at 16 centers in the U.S. The trial included patients with stenoses and occlusions that were greater than or equal to 70 percent and less than or equal to 100 percent of the vessel lumen within arteries four to seven millimeters in diameter. Three independent core labs analyzed the angiographic, intravascular ultrasound and duplex ultrasound data from the trial. The primary endpoints of the trial were the achievement of a minimum 20 percent reduction in the percent diameter stenosis post-laser compared to pre-intervention and major adverse events. The reduction in percent diameter stenosis following the use of the TURBO-Booster was 35 percent and there were no major adverse events reported through 30 days following the procedure. As a result, the primary endpoints were met. Further data included in the FDA submission showed a significant improvement in Rutherford scores and health assessment questionnaires at 30-days compared to pre-procedure.
"We believe approximately two-thirds of all endovascular procedures in the legs are in the larger diameter arteries above the knee,” said John G. Schulte, Spectranetics’ president and CEO. “We expect to complete the initial launch to our atherectomy account base of approximately 350 accounts within a period of four to five months.”
Spectranetics plans to initiate two clinical trials in 2007, one in the United States and one in Europe, to assess the effectiveness of the TURBO-Booster and existing peripheral atherectomy products for the treatment of in-stent restenosis.
For more information: www.spectranetics.com.