January 12, 2016 — NuCryo Vascular LLC announced that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance on the next-generation reusable cryoplasty inflation device. The company will be selling the current and next generation model via a direct sales team.
The PolarCath peripheral dilatation system received FDA clearance to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. It is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
The next-generation PolarCath system consists of a disposable catheter, a reusable inflation unit and a nitrous oxide cartridge. The system is used to perform balloon cryoplasty, a catheter-based treatment that combines the inflation of a balloon with controlled cooling of the artery. The system is used to dilate peripheral arteries with the same basic technique as balloon angioplasty, except that PolarCath uses nitrous oxide to inflate the balloon rather than liquid. The nitrous oxide cools the balloon to minus ten degrees Celsius, which freezes the built-up plaque in the artery.
“I am very excited with the FDA clearance of the next-generation reusable cryoplasty inflation device,” said Jack Casas, interventional cardiologist. “PolarCath, an FDA-cleared device with over a decade of extensive clinical experience, is an important tool in the treatment algorithm for peripheral arterial disease. The reusable unit will substantially lower the PolarCath per case procedural cost and will allow PolarCath to be used more frequently in today’s cost conscience market.”
For more information: www.nucryovasc.com