NuCryo Vascular Nabs Clearance for Cryoplasty Inflation Device

The FDA has awarded 510(k) clearance to devicemaker NuCryo Vascular’s next-generation reusable cryoplasty inflation device.

A catheter-based treatment that combines the inflation of a balloon with controlled cooling of the artery, the PolarCath peripheral dilatation system consists of a disposable catheter, a reusable inflation unit and a nitrous oxide cartridge.

The device is indicated to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of polytetrafluoroethylene access grafts or arteriovenous dialysis fistulae.

It also is indicated for post-deployed stent expansion of self-expanding peripheral vascular stents. — Michael Cipriano