Avinger (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced today that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its next generation Pantheris Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of peripheral artery disease.

As quoted in the press release:

The new version of Pantheris received CE Marking approval in December 2017, and patients have been successfully treated with this new device in Germany since that time.  Avinger’s next generation Pantheris device includes a number of design improvements, including a simplified single balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability, a reinforced nosecone with the option for more tissue storage capacity, and an enhanced cutter design. The Company intends to launch two versions of this product (standard and extended length nosecone) into initial sites in the U.S. immediately, and plans to incorporate the new design into the INSIGHT IDE clinical trial currently in progress. INSIGHT is a multi-center clinical study designed to evaluate the safety and effectiveness of Pantheris for treating in-stent restenosis (ISR) in lower extremity arteries. Distribution of the next generation Pantheris will be expanded as the Company increases production and gains purchasing approvals in additional Lumivascular sites.

“We are excited to introduce the next generation Pantheris to our network of physicians here in the United States,” said Mr. Jeff Soinski, Avinger’s President and CEO. “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.”

Click here to read the full press release.