The study aimed to analyze the effectiveness of the Pantheris during directional atherectomy procedures, the Redwood City, Calif.-based company said.
The Pantheris device is designed to be used to identify vessel lumen and wall structures including intima, internal elastic lamina, media, external elastic lamina and stent struts. The device is also designed to identify vessel morphologies including calcium, thrombus, fibroatheromas and necrotic cores.
Data from an interim sample of 55-patients in the trial indicated an 86% freedom from target lesion revascularization at 12 months and 82% freedom at 24 months. No amputations were reported through and statistically significant improvements in ankle brachial index and Rutherford classifications were reported at 30 days and maintained through 24 months.
Avinger reported that only 9.6% of lesions treated using standalone optical coherence tomography guided atheterctomy with the Pantheris received adjunctive drug coated balloon therapy, and only 5% received adjunctive stent therapy.
“These interim 24-month results demonstrate a stable, consistent, and high-functioning patient population through two years – impressive results for a study of mostly standalone, drug-free atherectomy cases. The findings are particularly striking considering that all data generation and outcomes were in the setting of a first-generation clinical trial device and brand new users,” Dr. Ian Cawich of the Arkansas Heart Hospital said in a prepared statement.
In a separate prospective case series of 30 patients, data indicated an 89% rate of primary patency at 6 months, and 86% at 12 months. OCT guided atheterctomy procedures reported an 84% standalone luminal gain, while OCT-guided CTO crossing reported 95% standalone true lumen crossing.
At 6 months, freedom from TLR was reported at 94.3%, similar to the 6-month results from the Vision trial. Freedom from TLR at 12 months was reported at 88%.
“As a new user, I am very encouraged by our positive long-term results. Lumivascular treatment demonstrated tremendous efficacy and safety, consistent with the larger pivotal Vision study,” Dr. Marianne Brodmann of Austria’s Medical University of Graz said in a press release.
Last month, Avinger said it won 510(k) clearance from the FDA for its Lightbox L250 imaging console. The software is designed to improve visualization inside vessels before, during and after Pantheris Lumivascular atherectomy procedures in patients with peripheral artery disease.