Avinger Inc. reported positive two-year clinical data from the pivotal VISION study of its Lumivascular technology. The VISION study was designed to evaluate the Redwood City, Calif.-based company's Pantheris system, which received FDA clearance last year. (See Medical Device Daily, March 10, 2016.) Interim results from 55 patients in the study were released at the Leipzig Interventional Course conference.

Pantheris is used for directional atherectomy while allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. The study was used to further clarify the utility of the device, said John Simpson, Avinger's founder and executive chairman.

"We have argued from the very beginning of the formation of Avinger, that if we can see inside the artery in a way that would allow us to treat the artery more safely and more predictably in better outcomes, that we could avoid things like stents and drugs," Simpson, told Medical Device Daily.

Data from the study showed that survival probability measured 86 percent freedom from target lesion revascularization (TLR) at 12 months and 82 percent freedom from TLR at 24 months.

A majority of lesions were treated using standalone optical coherence tomography guided atherectomy with the Pantheris catheter, with only 9.6 percent receiving adjunctive drug coated balloon (DCB) therapy and only 5 percent (n=10/198) receiving adjunctive stent therapy.

"We think for a two-year-follow up for an event analysis this is very compelling," Simpson added. "The critics will say we need to wait until the full data set is there. I think this data set looks so good because there is a consistent trend."

Joshua Jennings, an analyst with Cowen and Co. said the results were favorable and could help drive Pantheris' adoption rates.

"The positive durable efficacy data builds a stronger case for adoption of Pantheris as the evidence is highly competitive vs. results for DCB, bare metal stents and drug eluting stents," Jennings said. "We remain optimistic in the disruptive potential of Pantheris and the Lumivascular platform."

Pantheris incorporates lumivascular technology, which enables physicians to see inside the artery using optical coherence tomography. In the past, physicians, including Simpson, have had to rely solely on X-ray as well as touch and feel to guide their tools while they try to treat complicated arterial disease.

"I always found X-rays limiting," Simpson told Medical Device Daily. "I just couldn't see enough on the X-ray images to work safely on the arteries."

He said because of this conundrum he came up with the Pantheris concept – but ultimately the engineers at Avinger brought the concept to life.

Avinger is in plans to file a 510(k) submission of the next generation of Pantheris by the end of 2Q17. The device has an improved balloon inflation system and the balloon itself has undergone a re-design with a different material that affords higher compliance and more integrity.

"With the successful track record with the initial FDA approval of the Pantheris, the [company] could see a positive decision by late 3Q17 or early 4Q17," Jennings said.

The device goes up against some established contenders in the $400 million U.S. atherectomy market. One of the top technologies in the market is the Foxhollow line of catheters, which was acquired by Dublin-based Medtronic plc after several high profile mergers and acquisitions. Foxhollow Technologies Inc. and Avinger share a common tie – the med-tech entrepreneur Simpson.

He founded both companies and was once CEO of Foxhollow before it was acquired by Plymouth, Mass.-based Ev3 for $780 million in 2007.

About three years later, Covidien Ltd. acquired Ev3 for $2.3 billion in 2010. Medtronic then made its bid to acquire Covidien for $43 billion. (See Medical Device Daily, June 17, 2014.)