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NuCryo Vascular gets FDA 510(k) approval for next-generation cryoplasty inflation device

NuCryo Vascular has received 510(k) approval from the US Food and Drug Administration (FDA) for its next-generation PolarCath peripheral dilatation system.

The new reusable cryoplasty inflation device has been developed to dilate stenosis in the peripheral vasculature, including iliac, femoral, popliteal, infrapopliteal, renal, and subclavian arteries.

It was also approved to treat obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae.

According to the company, the PolarCath system is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

The system is comprised of a disposable catheter, reusable inflation unit and nitrous oxide cartridge. It is used to carry out balloon cryoplasty, a catheter-based treatment that combines the inflation of a balloon with controlled cooling of the artery.

PolarCath will be used to dilate peripheral arteries with the same basic technique as balloon angioplasty, but it uses nitrous oxide to inflate the balloon rather than liquid.

Interventional cardiologist Jack Casas said: "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."

The PolarCath system received its first FDA approval in 2002. It was developed by CryoVascular, a company acquired by Boston Scientific in 2005.