FDA adds diagnostic indication for Avinger’s Pantheris atherectomy device

Avinger (NSDQ:AVGR) said today it won expanded indications from the FDA for its Pantheris Lumivascular atherectomy system, now cleared for diagnostic imaging as well as treatment for peripheral artery disease.

The Redwood City, Calif.-based company touted the win, saying its Pantheris is the 1st and only image-guided atherectomy device to receive clearances as both a diagnostic imager and treatment platform for PAD.

“I am thrilled that Pantheris is now recognized as providing important diagnostic imaging information that enhances physicians’ ability to deliver the most advanced treatments for vascular disease. This is one more step toward establishing Lumivascular technology as a premier interventional platform for physicians,” founder & exec chair John Simpson said in prepared remarks.

The Pantheris device is designed to be used to identify vessel lumen and wall structures including intima, internal elastic lamina, media, external elastic lamina and stent struts. The device is also designed to identify vessel morphologies including calcium, thrombus, fibroatheromas and necrotic cores.

“The FDA clearance of Pantheris as a diagnostic tool reflects what we as clinicians have already seen first-hand in our practices: that Pantheris OCT images provide important clinical information during our procedures, allowing us to see complicated plaque characteristics in real time as we treat the vessel. With Pantheris, we can now reliably assess disease extent while simultaneously treating disease, allowing a greater level of accuracy and confidence,” Dr. Suhail Dohad of Los Angeles’ Cedars Sinai Hospital said in a press release.

In August, Avinger priced a follow-on offering worth $30 million, saying it plans to dip into the cash if it needs to cover penalties for missed revenue covenants this year.

Avinger said it plans to float nearly 8.6 million shares at $3.50 apiece, plus a possible 1.3-million-share underwriters over-allotment that could bring in another $4.5 million. The offering is slated to close August 16, Avinger said. The company makes devices to treat peripheral vascular disease.

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