About Us

NuCryo Vascular LLC

History

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.


Frequently Asked Questions

Find your question from below or submit your question from the submit box.


  • Why did Boston Scientific divest the PolarCath Balloon Dilatation System?

    After Boston Scientific purchased Guidant for $27 Billion, Boston made a corporate strategic decision to divest technology that was not associated with the CRM or coronary franchises and that was not manufactured in Maple Grove, Galway, or Massachusetts.

  • How does Cryoplasty data compare to DCB data for patency?

    The primary patency for PolarCath in the IDE trial based on a PSVR of 2.5 (same PSVR used in DCB trials) was 81%

  • Why should I use Cryo to post dilate a stent instead of standard PTA?

    The COBRA study was a multi-center, randomized study of PTA vs Cryo in the post dilation of nitinol stents in diabetic patients. The study provided that post dilation of nitinol stents minimized binary restenosis by nearly 50% at 12 months!

  • What has changed since NuCryo has purchased the rights from Boston Scientific?

    NuCryo Vascular has received two 510(k) approvals since buying the rights back in August 2014. The latest was in October 2015 when the non-sterile reposable inflation unit was approved to replace the deposable, sterile unit. This approval lowered the cost per case by nearly 50%.

  • What size is the PolarCath Balloon Dilatation System available in?

    PolarCath is available on the 014 platform in diameters of 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, and 6.0 and in lengths of 40, 100, and 150.
    PolarCath is available on the 035 platform in diameters of 4.0, 5.0, 6.0, and in lengths of 40, 100, and 150. It is also available 7.0 and 8.0 x 40.

  • Are there plans for additional clinical research for PolarCath?

    Absolutely, we are currently working on protocols for new studies to support PolarCath in the treatment of peripheral vascular disease.


Investors

NuCryo Vascular is a privately held medical device start-up that is based in Silicon Valley.
The company is currently funded through initial seed money and private equity.

Testimonial