PolarCath Balloon Dilatation System image courtesy of NuCryo Vascular
March 28, 2016 — NuCryo Vascular LLC announced the launch of the Next Generation Cryoplasty Inflation device. The device received U.S. Food and Drug Administration (FDA) 510(k) clearance in late 2015 and works in conjunction with the PolarCath Balloon Dilatation System.
The benefits of the new device include:
- Non-sterile, reposable unit providing up to 100 inflations (treatments); and
- Drastically reduces the cost per case of the PolarCath system.
The PolarCath Balloon Dilatation System is the first and only therapeutic device, according to NuCryo, that combines an angioplasty balloon with precision cooling. Balloon cryoplasty uses liquid nitrous oxide to cool the balloon to -10°C. Cryoplasty’s unique mechanism of action facilitates uniform vessel dilation, reduced vessel recoil and smooth muscle cell apoptosis.
Balloon cryoplasty has been shown in clinical studies to be clinically effective in treating peripheral vascular disease. The BTK Chill study demonstrated 85.2 percent limb salvage in critical limb ischemia patients with infrapopliteal lesions. The COBRA trial, in patients with diabetes mellitus, determined that post-dilation of nitinol self-expanding stents in the superficial femoral artery (SFA) using PolarCath reduced 12-month in-stent restenosis by nearly 50 percent compared to conventional balloon post-dilatation.
For more information: www.nucryovasc.com