Insurer launches trial of Avinger’s Pantheris atherectomy device

Avinger (NSDQ:AVGR) said yesterday that it is collaborating with health insurers Highmark Health and Allegheny Health Network to launch a trial of its Pantheris image-guided atherectomy device designed for treating peripheral artery disease.

The Pantheris device is designed to use optical coherence tomography to allow physicians to visualize the vessel and obstruction during atherectomy procedures to treat peripheral artery disease.

“Using this technology, we now have the ability to clearly see our way through the artery. This means there is less risk of damaging the artery walls, which can lead to an aggressive healing-and-scarring process that increases the risk of restenosis, or a re-narrowing of the artery after treatment,” Allegheny Health Network vascular surgery director Dr. Satish Muluk said in prepared remarks.

The partnership, and the study, are part of Highmark Health’s “verification of innovation by testing, analysis and learning” – known as Vital – innovation program, Avinger said. The program plans to evaluate the Pantheris device in terms of benefits to patients, providers and payers through the “holistic” evaluation of patient care, the company said.

“PAD is not an isolated problem. It is part of a disease spectrum that often involves diabetes, high blood pressure, cardiac abnormalities and renal insufficiencies. Accordingly, optimal PAD therapy should aim to understand, treat and improve both local and systemic disease effects. By linking delivered care with claims data in a collaborative environment, Vital is changing the conversation about episodic care and redefining what quality means,” Avinger CMO Dr. Arjun Desai said in a press release.

The Vital study will evaluate PAD patients treated with both the Ocelot and Pantheris lumivascular catheter devices, with acute and long-term outcomes compared against a historic cohort of both endovascular and surgical therapies, Avinger said.

A follow-up study will include claims data analysis investigating the evolution of the patient and related co-morbidities during the post-treatment period, the company said.

“Vital’s mission is to support bringing safe, innovative technologies to members and patients that increase quality of care and lead to better patient outcomes without undue financial burden. As one of the largest integrated health care delivery and financing systems in the nation, we embrace our responsibility to accelerate the pace with which novel technologies and services are made available to the public,” Highmark Health CEO David Holmberg said in a prepared statement.

In March, Avinger launched a new version of its Pantheris peripheral atherectomy device and registered for the sale of up to $50 million worth of its stock.

Redwood City, Calif.-based Avinger said the deal with Cowen & Co. doesn’t oblige it to sell any shares. Earlier in March, the company said it would immediately launch an enhanced version of the Pantheris device after winning FDA clearance. Pantheris won its 1st nod from the agency in October 2015; Avinger said the new version features improved ergonomics, physician controls and manufacturability.

Avinger floated a $65 million initial public offering in January 2015. Last September the company pulled in a $55 million term loan.

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