Avinger is pursuing a number of different indications to effectively position its Pantheris lumivascular atherectomy system to treat peripheral arterial disease (PAD) in a variety of different patients.
The Redwood City, CA-based company’s latest news on this front is its submission of a 510 (k) application to FDA for the Pantheris Small Vessel (SV) Lumivascular atherectomy system.
“We also plan on filing for CE mark for clearance of the small vessel device in Europe soon after our U.S. submission,” Jeff Soinski, Avinger CEO, said according to a Seeking Alpha Transcript.
The company said it was hopeful the device could be cleared in the U.S. sometime in 2019.
With a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to target lesions in smaller diameter vessels and more distal regions of the vasculature.
The firm has been busy pursuing a slew of indications for the Pantheris platform, which has been available in the US market since 2016. In May, Avinger received FDA clearance for its next generation Pantheris image-guided atherectomy device. The technology has been successful thus far the company said.
“Based upon the positive case experience and impressive clinical outcomes in initial sites in the U.S. and in Germany beginning earlier this year, we made the decision to launch the next-generation Pantheris more broadly to our installed base in June,” Soinski said according to a Seeking Alpha Transcript. “Since that time, we've discontinued all sales of our previous version of Pantheris in both the U.S. and in Europe and are now selling the next-generation device in two versions, the A400, which has a standard nosecone and the A400X with an extended nosecone with the ability to capture up to 70% more plaque in a single insertion.”
Avinger executives spoke with MD+DI in March and said the company is working to secure an indication to treat in-stent restenosis (ISR). In October of 2017, patient enrollment began to evaluate the safety and effectiveness of Pantheris when treating ISR. The study is expected to enroll up to 140 patients in 20 sites. The company said ISR represents about 20% of PAD procedures in the U.S.
The company would have a six-month-follow up for the patients, which should be complete in 2019. The firm would submit to FDA sometime after.