NuCryo Vascular receives 510(k) clearance for PolarCath reusable cryoplasty inflation device


NuCryo Vascular has received 510(k) clearance for its reusable cryoplasty inflation device. NuCryo will be selling the current and next generation model via a direct sales team.

The PolarCath peripheral dilatation system received Food and Drug Administration (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. PolarCath is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents. The PolarCath system was invented 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 -10 degrees Celsius, which freezes the built-up plaque in the artery.

“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,” says Jack Casas, an interventional cardiologist. “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-conscious market.”

“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.”