Vascular Solutions Begins Sales of Polarcath Peripheral Dilatation System

Minneapolis, Minn.-based Vascular Solutions, Inc. has begun sales for the Polarcath peripheral dilatation system in the United States in collaboration with NuCryo Vascular LLC, the manufacturer of the product.

Vascular Solutions entered into an agreement with NuCryo in November last year to serve as the exclusive U.S. distributor of the Polarcath product line. Vascular Solutions is projecting between $3 million to $5 million in sales of the system during 2015.

The PolarCath peripheral dilatation system is indicated for use in dilating stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The Polarcath system is also indicated for post-deployment stent expansion of self-expanding peripheral vascular stents.

“With more than a decade of extensive clinical experience, PolarCath has an important role in the treatment of peripheral arterial disease,” said Howard Root, CEO of Vascular Solutions. “The product is a natural fit for our U.S. direct sales force and our focus on meeting the needs of interventional vascular physicians. Beginning today, we have available the wide range of 0.014” guidewire-compatible PolarCath balloon catheters which target mainly below-the-knee interventions. Later this year, we will add the 0.035” guidewire-compatible versions of the PolarCath balloon catheters which generally target above-the-knee interventions.”

The PolarCath peripheral dilatation system consists of a balloon catheter, an inflation unit, and a nitrous oxide cartridge. Use of the Polarcath system simultaneously dilates and modifies atherosclerotic plaque. Once delivered to the lesion, the Polarcath balloon is inflated with nitrous oxide gas, which cools the vessel wall during a 20-second treatment at -10°C. The PolarCath peripheral dilatation system was invented by James Joye, D.O., an interventional cardiologist focused on pioneering new vascular treatments.

“Balloon cryoplasty has been shown in clinical studies and in everyday practice to be an important option for treating peripheral arterial disease, which in patients with severe PAD can lead to below-the-knee amputations,” Joye said. “The controlled cooling of the plaque and artery wall provides three 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.”

The Polarcath system, which first received U.S. Food and Drug Administration  clearance in 2002, was developed by CryoVascular Inc., a company formed by Joye and collaborators. In 2005, CryoVascular was acquired by Boston Scientific, which discontinued manufacturing PolarCath at the end of 2012. NuCryo Vascular was formed by Joye and several of the former CryoVascular executives and employees for the purpose of acquiring Polarcath and resuming manufacturing of the device. NuCryo Vascular has established a manufacturing facility for PolarCath in Sunnyvale, Calif.