Avinger presents data on treatment of in-stent restenosis with Pantheris

Avinger announced the presentation of clinical data from the INSIGHT study during the Charing Cross International Symposium in London, England. The CX Symposium is a leading vascular and endovascular education conference focused on education, innovation, and evidence. The INSIGHT trial was designed to evaluate the safety and effectiveness of Avinger’s Pantheris image-guided atherectomy system for treating in-stent restenosis in lower extremity arteries. Dr. Arne Schwindt, a vascular surgeon and endovascular interventionist in one of Germany’s leading endovascular centers at St. Franziskus Hospital in Munster, presented 6 and 12-month follow-up results in his presentation entitled "Treatment of In-stent Restenosis with an Atherectomy Catheter: Results from the INSIGHT Study." Data from the study supported the subsequent 510(k) clearance by the U.S. Food and Drug Administration for an expanded in-stent restenosis indication for Pantheris. Key outcomes presented from the trial include: 82% luminal gain following the procedure; 93% freedom from target lesion restenosis at 6 months post-procedure; 89% freedom from target lesion restenosis at 12 months post-procedure; No amputations for the 6 or 12-month cohorts of patients; 0.96 mean ankle-brachial index at 6 months from a baseline of 0.69 pre procedure; 71% improvement in Rutherford Class at 6 months. INSIGHT is a prospective, global, single-arm, multi-center trial conducted at 17 sites. The primary safety endpoint was freedom from major adverse events through 30-day follow-up and the primary and secondary effectiveness endpoints were the proportion of target lesions with a residual diameter stenosis less than 50% post-atherectomy, and freedom from TLR at 6 months, respectively. An independent core lab adjudicated all images and a clinical events committee assessed adverse events. While 30-day and 6-month endpoints support the expanded clinical indication, patients were followed out to 12-months to track longer term outcomes. EXCITE-ISR was a randomized controlled study comparing laser atherectomy plus percutaneous transluminal angioplasty versus angioplasty alone for treatment of femoropopliteal in-stent restenosis.