NuCryo Vascular gets 510(k) clearance for next generation reusable Polarcath peripheral dilatation system


NuCryo Vascular has announced receiving 510(k) clearance on the next generation reusable Cryoplasty inflation device. The company has also announced that it will be selling the current and next generation model via a direct sales team.

The Polarcath peripheral dilatation system received US FDA clearance to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The Polarcath system is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents. The system was invented in Mountain View, USA, by James Joye, an interventional cardiologist and a pioneer in developing medical devices to treat peripheral arterial disease.

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 PolarCath 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.

“The clearance of the next generation, reusable device is a huge milestone and highlights the engineering advancements we have made in the PolarCath system since reacquiring the rights back in 2014,” stated Joye. “Balloon cryoplasty has been shown in clinical studies and in everyday procedures to be an important option for treating peripheral arterial disease. The controlled cooling of the plaque and artery wall provides three potential benefits: uniform vessel dilation with less vessel trauma; reduced vessel wall recoil; and induction of apoptosis, promoting the natural cell death of the smooth muscle cells that otherwise proliferate to cause restenosis.”

The PolarCath system, which received its first FDA clearance in 2002, was developed by CryoVascular, a company formed by Joye and collaborators. In 2005, CryoVascular was acquired by Boston Scientific, which discontinued manufacturing PolarCath at the end of 2012. NuCryo Vascular was formed by Joye and several of the former CryoVascular executives and employees for the purpose of acquiring PolarCath and resuming manufacturing of the device.