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Peripheral laser atherectomy devices receive FDA clearance for in-stent restenosis

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Spectranetics announced that it has received 510(k) clearance from the FDA for the Turbo-Tandem and Turbo Elite peripheral laser atherectomy devices for the treatment of in-stent restenosis among patients with peripheral artery disease.

The new FDA clearance follows results from the multicenter, prospective EXCITE ISR trial, which included patients randomly assigned to receive either laser atherectomy in combination with percutaneous transluminal angioplasty (PTA) or PTA alone, according to a press release release.

The primary efficacy endpoint was freedom from target limb revascularization at 6 months and the primary safety endpoint was freedom from major adverse events, including major amputation in the target limb, target limb revascularization and all-cause mortality at 30 days. The trial was initially designed to enroll 318 patients at up to 35 centers; however, Spectranetics announced early success after observing significant superiority for safety and efficacy in the treatment group after 250 patients were enrolled (procedural success, 94% treatment group vs. 83% PTA only group). The cohort had a mean lesion length of approximately 20 cm and included only those with complex or advanced disease, according to the release.

“With mean lesion length at 20 centimeters, approximately one-third of the patients being re-treated for [in-stent restenosis] and also approximately one-third with total occlusions, EXCITE represents a very sick, real-world patient set,” Eric Dippel, MD, of Genesis Heart Institute, said in the release. “The highly superior outcomes for both safety and efficacy and the delta in procedural success rates between the two arms of the trial are compelling. Given that a significant number of patients today are treated with PTA alone with very poor outcomes, EXCITE demonstrates a proven treatment algorithm that physicians and their patients need.”

Complete results from the EXCITE trial have been submitted to a peer-reviewed medical journal, according to the release.