In less than 60 days after submitting its application, Spectranetics (Colorado Springs, Colorado) said it has received FDA clearance to market its Turbo-Booster product for the treatment of arterial stenoses and occlusions in the leg, which represents a broader indication for use as compared to current labeling of the existing peripheral laser catheters, the company noted.
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 Turbo elite laser catheters allows for removal of large amounts of plaque material within the superficial femoral artery (SFA) and popliteal arteries, Spectranetics said.
The company reported submitting its 510(k) application for clearance of its Turbo-Booster in May (Medical Device Daily, May 11, 2007). That news came just two months after the company reported halting its CELLO trial, with the FDA’s approval, after completing about three quarters of enrollment. The trial was stopped, the company told Medical Device Daily at the time, because its preliminary data was strong enough to meet the endpoints (MDD, March 16, 2007).
“I think we’ve had a good relationship with the FDA,” Will McGuire, COO of Spectranetics, told MDD. “I think we had a good and open dialogue with the FDA from the beginning. We were very clear about what we wanted to do, and they were very clear about what we needed to do.”
McGuire called the Turbo-Booster a “market-expanding product” for Spectranetics, because it will help the company enter the above-the-knee market.
“The important thing for us is right now two-thirds of our catheters are used below-the-knee, and the Turbo-Booster allows us to make larger channels, or larger holes, [in above-the-knee procedures],” McGuire said.
The CELLO trial, the study conducted to provide data to FDA in support of the clearance for the Turbo-Booster, 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% and less than or equal to 100% of the vessel lumen within arteries 4 to 7 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% 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%, 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, Spectranetics said.
“We are very pleased with the clinical data from the CELLO trial, and the subsequent positive response from the FDA, which places our Turbo-Booster program well ahead of the original timeline. Turbo-Booster significantly expands our addressable market, as we believe approximately two-thirds of all endovascular procedures in the legs are in the larger diameter arteries above the knee,” said John Schulte, Spectranetics’ president/CEO. “Our current plan is to immediately begin a controlled release of the product to specified accounts over the next 30 days, which will allow for collection of valuable feedback to help guide our training and marketing programs. We expect to complete the initial launch to our atherectomy account base of about 350 accounts within a period of four to five months. After completion of the initial phase of the launch and receiving clinical and marketing feedback regarding the performance of the Turbo-Booster, we will update our annual financial guidance, which we expect to occur during our investor conference call discussing third quarter financial results in late October.”
McGuire said the company expects to initiate two clinical trials in the second half of this year, one in the U.S. and one in Germany, to assess the effectiveness of the Turbo-Booster and existing peripheral atherectomy products for the treatment of in-stent restenosis.
Founded in 1984, Spectranetics says it makes the only excimer laser approved in the U.S., 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 bloodstream. 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.