FDAnews
www.fdanews.com/articles/67773-early-research-suggests-cryoplasty-therapy-may-save-legs

EARLY RESEARCH SUGGESTS CRYOPLASTY THERAPY MAY SAVE LEGS

January 20, 2005

One-hundred percent of people facing almost-certain amputation were successfully treated with a new nonsurgical therapy that gently cools and opens leg arteries clogged with plaque, according to preliminary data on 22 patients presented at the 17th Annual International Symposium on Endovascular Therapy.

The PolarCath System is a proprietary technology for delivering the CryoPlasty therapy developed by CryoVascular Systems. First available in August 2004 to treat patients with arteries that are blocked below the knee, the new CryoPlasty therapy is now offered at nearly 800 sites in the U.S., including most major hospitals.

CryoPlasty therapy involves the use of nitrous oxide, rather than saline, to inflate a catheter balloon and cool it to -10 degrees. This prompts several physical responses that open the artery and cause less scarring than occurs with traditional angioplasty. The below-the-knee CryoPlasty procedure is performed using one of several new smaller-sized catheters, which have received clearance from the FDA, the company said.