The bid for 510(k) clearance from the federal safety watchdog for the image-guided device covers new features including a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. The new Pantheris is designed to treat blocked peripheral blood vessels, using Avinger’s Lumivascular optical coherence tomography technology.
“We have received invaluable feedback from physician users that our engineering team has incorporated into the design of our next generation of Pantheris,” president & CEO Jeff Soinski said in prepared remarks. “The upgraded features captured in this submission should bring the next level of quality, efficiency and ease of use to the product. We are hopeful that this filing will lead to FDA clearance of the next generation device in the U.S. by early next year, which would allow the product to be commercially available by the end of the first quarter.”
“The Pantheris Lumivascular atherectomy system, through its combination of onboard image-guidance and directional plaque removal, has changed my approach to treating peripheral artery disease. As a regular user of the current version of Pantheris, I believe the proposed enhancements represent an important step forward, and I am excited to incorporate the next generation Pantheris into the mainstream of my PAD treatment algorithm,” added Dr. Patrick Muck of Cincinnati’s Good Samaritan Hospital.
Yesterday Redwood City, Calif.-based Avinger said it won CE Mark approval in the European Union for the newer device, after winning an in-stent restenosis nod there in September. In October 2016, Avinger won expanded indications from the FDA for Pantheris for diagnostic imaging as well as treatment for peripheral artery disease.