Spectranetics Boosted by FDA Clearance

Spectranetics, of Colorado Springs, CO, has received FDA clearance for its TURBO-Booster device for the treatment of arterial stenoses and occlusions in the leg. Used in combination with Spectranetics’ existing TURBO elite laser catheters, the TURBO-Booster functions as a guiding catheter that facilitates ablation of blockages in the main arteries at or above the knee.

Back in March, Spectranetics stopped enrolling patients in its trial for the device after the company and FDA agreed that data gathered from 61 patients was sufficient for FDA review. (Original plans called for 85 enrollees.) The firm filed a 501(k) application in May.

Still, CEO John Schulte said today in a statement that the nod from FDA came sooner than expected, adding, “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.”

Schulte went on to discuss next steps: “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 approximately 350 accounts within a period of four to five months.”

Also in the works, Spectranetics will initiate two clinical trials this year, one in the U.S. and one in Europe, to assess the effectiveness of TURBO-Booster at treating in-stent restenosis.

Last month, Spectranetics ranked number 62 on the FSB 100, Fortune Small Business‘ annual ranking of public companies with revenues of under $200 million. This is the second year in a row that the firm made the list of fast-growing companies.

The comments are closed.