Avinger Inc. (NASDAQ: AVGR) jumped 3.6% after announcing the submission of a 501(k) application to the FDA for new Pantheris indication in in-stent restenosis (SIR) treatment in the lower extremity arteries.
Avinger’s atherectomy products show promise in in-stent restenosis treatment.
Commenting on the submission, Avinger CEO and President Jeff Soinski said, “We are extremely pleased with this milestone and the initial clinical data generated from the INSIGHT trial that supports the 510(k) submission. The safe and effective treatment of in-stent restenosis is an important clinical benefit, which we believe will provide a highly differentiated competitive advantage for Avinger’s atherectomy products. With the large number of stents deployed in the lower extremity arteries, and the propensity for recurrence over a 2-to-3-year timeframe, the sheer number of ISR procedures performed in the U.S. each year provides a significantly expanded market opportunity for Pantheris, if our 510(k) application for this additional clinical indication is approved.”
Around 200,000 stents are implanted annually.
With about 200,000 stents implanted in the popliteal and femoral arteries each year, 30-40% of these stents are likely to develop in-stent restenosis after three years of installation. Thus, the in-stent restenosis treatment represents a potential market and healthcare need. However, when it comes to treating ISR, physicians frequently confront hurdles regarding both safety and efficacy.
From a safety aspect, shortcomings in imaging procedures such as X fluoroscopy and the failure to handle the selectivity of several other treatment options raise concerns about the stent’s integrity being compromised throughout the procedure. In addition, current therapy for in-stent restenosis, including balloon angioplasty, have significant rates of a recurring stent.
To support the submission for the new indication, the company used data from the INSIGHT trial, which evaluated the efficacy and safety o the Pantheris atherectomy system in in-stent restenosis treatment.