FDA Clears NuCryo Vascular's Next-Generation Reusable Cryoplasty Inflation Device

January 4, 2016—NuCryo Vascular LLC announced that the company has received US Food and Drug Administration 510(k) clearance for the next-generation reusable Cryoplasty inflation device. NuCryo Vascular LLC also advised it 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 (iliac, femoral, popliteal, infrapopliteal, renal, and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene access grafts or arteriovenous dialysis fistulae. The PolarCath system is also indicated for postdeployed stent expansion of self-expanding peripheral vascular stents.

The next-generation PolarCath peripheral dilatation system consists of a disposable catheter, a reusable inflation unit, and a nitrous oxide cartridge. 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 -10º C, which freezes the built-up plaque in the artery.

The PolarCath system was invented by interventional cardiologist James Joye, DO. In the company’s announcement, Dr. Joye stated, “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. 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.”

Interventional cardiologist Jack Casas, MD, also commented in the press release, “I am very excited with the FDA clearance of the next-generation reusable Cryoplasty inflation device. 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-conscious market.”