NuCryo Vascular to Take Over Manufacturing and Marketing of PolarCath Cryoplasty System

November 16, 2015—Vascular Solutions, Inc. and NuCryo Vascular, LLC announced that they have mutually terminated the agreement under which Vascular Solutions has been serving as exclusive distributor of the PolarCath peripheral dilatation system in the United States. Effective December 31, 2015, Vascular Solutions will no longer distribute the PolarCath products. NuCryo Vascular will take over all sales, marketing, and customer service activities for the PolarCath products, which are manufactured by NuCryo.

The PolarCath system was invented by James Joye, MD, and originally developed by CryoVascular, Inc. In 2005, CryoVascular was acquired by Boston Scientific Corporation, which discontinued manufacturing PolarCath at the end of 2012. NuCryo Vascular was formed by Dr. 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, California.

The PolarCath system consists of a disposable catheter, an inflation unit, and a nitrous oxide cartridge. The system is used to perform balloon cryoplasty to dilate peripheral arteries with the same basic technique as balloon angioplasty, except that PolarCath uses nitrous oxide, rather than liquid, to inflate the balloon. The nitrous oxide cools the balloon to -10º C, which freezes the built-up plaque in the artery.

The US Food and Drug Administration cleared the PolarCath in 2002 to dilate 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 fistulae. The PolarCath system is also indicated for postdeployed stent expansion of self-expanding peripheral vascular stents, advised the company.