NuCryo Vascular was created in 2014, after buying the PolarCath Peripheral Dilatation Balloon System back from Boston Scientific. The PolarCath system is a peripheral dilatation system that combines angioplasty and precise cryotherapy (cooling) to uniformly dilate peripheral vessels and reduce recoil, dissections, and restenosis.
The PolarCath system was first launched in the U.S. in 2003 by Cryovascular Systems, Inc. PolarCath was then purchased by Boston Scientific in 2005, where sales grew to over $40 million annually by 2008. In 2012, after Boston Scientific's purchase of Guidant and the subsequent reorganizing, Boston stopped manufacturing the PolarCath product. In the same timeframe, the positive COBRA study was published showing superior efficacy and safety in the post dilation of nitinol stents in the diabetic patient.
NuCryo Vascular received 510(k) approval for the next generation reposable, non sterile inflation unit in October 2015 and began selling through a direct sales team in the United States in January 2016.
The PolarCath System was originally developed in the late 1990's by Dr. James Joye, a serial entrepreneur and pioneering interventional cardiologist.