Technology | Balloon Catheter | March 28, 2016

NuCryo Vascular Announces Launch of Next Generation Cryoplasty Inflation Device

Non-sterile reposable unit works in conjunction with PolarCath Balloon Dilatation System to treat peripheral vascular disease

NuCryo Vascular, Next Generation Cryoplasty Inflation Device, PolarCath Balloon Dilatation System

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

Related Content

Cardiovascular Systems Expands Product Portfolio for Peripheral and Coronary Interventions
News | Balloon Catheter | January 24, 2018
Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s product portfolio. CSI is...
Abbott recalls its NC Balloon catheters
News | Balloon Catheter | May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports
Videos | Balloon Catheter | November 16, 2016
A discussion with Todd Brinton, M.D., about the newly FDA-cleared Shockwave Medical Lithoplasty System, at the Transc
NuCryo Vascular, FDA clearance, next-gen, PolarCath System, cryoplasty inflation device
Technology | Balloon Catheter | January 12, 2016
NuCryo Vascular LLC announced that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance on the...
Videos | Balloon Catheter | October 30, 2015
Todd Brinton, M.D., clinical associate professor and consulting associate professor of bioengineering at Stanford Uni
Overlay Init