The inventor of the PolarCath technology, a cryoplasty device used to treat peripheral artery disease, bought the device back from Boston Scientific (NYSE:BSX) and plans to have it back on the market early next year, according to a press release.
Dr. James Joye founded CryoVascular Inc. to commercialize the PolarCath device he developed as chief medical officer of the Fogarty Institute in Mountain View, Calif. PolarCath won 510(k) approval from the FDA in 2002.
In 2005, Boston Scientific paid $50 million plus milestones (and a prior, $10 million strategic investment) for CryoVascular, but by 2011 the PolarCath technology was no longer mentioned in the company’s annual regulatory filing; Boston shelved the device in late 2012, according to the release.
That prompted Joye and several other ex-CryoVascular executives to found NuCryo Vascular last July to buy the tech back from Boston Scientific and start making it again at a plant in Sunnyvale, Calif.
Like balloon angioplasty, the PolarCath device uses a balloon to dilate plaque obstructions in the peripheral arteries of the leg. But unlike other, conventional balloons, the PolarCath uses nitrous oxide to freeze the plaque at -10°C (-14°F).
“Balloon cryoplasty has been shown in clinical studies and in everyday practice to be an important option for treating peripheral arterial disease, which can lead to below-the-knee amputations in patients with severe PAD,” Joye said in prepared remarks. “The controlled cooling of the plaque and artery wall provides 3 potential benefits: uniform vessel dilation with less vessel trauma; reduced vessel wall recoil; and induction of apoptosis, promoting the natural cell death of the smooth muscle cells that otherwise proliferate to cause restenosis.”
Vascular Solutions said it plans to begin selling the PolarCath device during the 1st quarter of 2015; revenues are expected to be between $3 million and $5 million during 2015, the company said.
“We are very excited to add PolarCath to our broad line of clinical solutions for the treatment of vascular disease,” CEO Howard Root said in a statement. “PolarCath, an FDA cleared device with more than a decade of extensive clinical experience, is an important tool for the treatment of peripheral arterial disease. The product is a natural fit for our U.S. direct sales force and our focus on meeting the needs of interventional physicians.”