PolarCath - The "Cool" Peripheral Dilatation System
About Us
NuCryo Vascular LLC
  • 2012 : Boston Scientific reorganizes and stops manufacturing and promoting  PolarCath but continues selling inventory.  Positive COBRA clinical study published
  • 2013: PolarCath sales continue from Boston Scientifics inventory with sales > $5.3 million in the U.S. with > 100 accounts
  • 2014: NuCryo Vascular is formed by Dr. Joye, who aquired PolarCath from Boston Scientific to begin  engineering improvements and manufacturing units for commercialization. NuCryo Vascular also signs an exclusive distribution agreement with Vascular Solutions for US sales distribution in 2015
  • 2015:  NuCryo Vascular terminates distribution deal with Vascular Solutions and receives 510(k) approval for next generation reusable Cryoplasty inflation unit
  • 2016: NuCryo Vascular hires direct sales force to bring PolarCath system to market under NuCryo Vascular LLC
 
NuCryo Vascular is a subsidiary of Gemini Interventional Technologies LLC.  Gemini Internvetional Technologies is an umbrella company focused on developing, manufacturing and bringing to market unique and differentiated medical device products for the peripheral arterial space.
 
NuCryo Vascular LLC was created in 2014, after buying the rights from Boston Scientific to engineer, manufacture, and bring the PolarCath Peripheral Dilatation Balloon System to market. 
 
The PolarCath system, which was first launched in the U.S. in 2003, has proven to be an important option for treating peripheral arterial disease (PAD).   PolarCath is a periphearl dilatation system that combines angioplasty and precise cryotherapy (cooling) to uniformly dilate peripheral vessels and reduce recoil, dissections, and restenosis. 
    
The PolarCath System was originally developed in the late 1990's by Dr. James Joye, an interventional cardiologist, in Mountain View, CA. in an effort to overcome the limitations of peripheral arterial angioplasty.   Below is a timeline showing the life of PolarCath:
 
  • 1998 : Dr. Joye files for first patent on the cryoplasty device for cryogenic inhibition of hyperplasia
  • 1999: Cryovascular Systems Inc. formed
  • 2002: Initial patent granted and first 510(k) clearance
  • 2003: Boston Scientific begins distributing PolarCath
  • 2005: Boston Scientific acquires Cryovascular Systems
  • 2008: Annual PolarCath sales peak at >$40 million and >450 accounts in the United States