Vascular Solutions Launches PolarCath Peripheral Dilatation System in United States

March 16, 2015—Vascular Solutions, Inc. announced that it has commenced sales of the PolarCath peripheral dilatation system in the United States in collaboration with the product’s manufacturer, NuCryo Vascular LLC.

The PolarCath system is indicated for use in dilating stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene access grafts or arteriovenous dialysis fistulas. The system is also indicated for postdeployment stent expansion of self-expanding peripheral vascular stents. It consists of a balloon catheter, an inflation unit, and a nitrous oxide cartridge. The balloon is delivered to the lesion and inflated with nitrous oxide gas, which cools the vessel wall during a 20-second treatment at -10° C. The use of PolarCath simultaneously dilates and modifies atherosclerotic plaque, the company stated.

James Joye, DO, an interventional cardiologist who is focused on pioneering new vascular treatments, is the inventor of PolarCath. “Balloon cryoplasty has been shown in clinical studies and in everyday practice to be an important option for treating peripheral arterial disease [PAD], which in patients with severe PAD can lead to below-the-knee amputations,” stated Dr. Joye in the company’s press release. “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.”

In November 2014, Vascular Solutions entered into an agreement with NuCryo to become the exclusive United States distributor of the PolarCath line of products. Vascular Solutions is projecting between $3 million and $5 million in PolarCath sales during 2015, the company stated in its press release.