Avinger (NSDQ:AVGR) said today it won FDA 510(k) clearance for its next-gen Pantheris lumivascular atherectomy system, which it touts as the first image-guided atherectomy device designed for treating peripheral artery disease.
Redwood City, Calif.-based Avinger said the newly cleared Pantheris device features a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. The system is designed to treat blocked peripheral blood vessels, using its Lumivascular optical coherence tomography technology, the company added.
“We are excited to introduce the next generation Pantheris to our network of physicians here in the United States. After extensive testing by our R&D and operations teams, physician design validation, and successful initial case experience in Europe across a variety of different lesion types, we believe this next generation device will significantly improve the user experience in terms of reliability, efficiency, and ease of use across a spectrum of clinical situations,” prez & CEO Jeff Soinski said in a prepared statement.
The system won CE Mark approval in the European Union last December, and has been actively used in Germany since winning approval, the company said.
Avinger said it plans to launch two version of the device at initial sites in the US immediately, and will incoporate the new design into an IDE clinical trial currently in progress examining the use of the system for treating in-stent restenosis in lower extremity arteries.
“The Pantheris Lumivascular atherectomy system has allowed me to treat peripheral artery disease with more precision while largely avoiding trauma to the blood vessel during an intervention. Unlike some other products, this technology’s performance can stand on its own but also enhance other forms of adjunctive therapy if needed, while preserving future treatment options for the patient. As one of the first users of the initial generations of Pantheris, I have been eagerly awaiting the product enhancements incorporated into the new system, which has the promise of not only improving ease of use, but also providing a new level of operator control during the procedure,” Dr. Barry Tedder of Jonesboro, Ark.’s St. Bernards Medical Center said in a press release.
