Vascular Solutions Announces Launch of 0.035-Inch Catheters for PolarCath System
August 3, 2015—Vascular Solutions, Inc. announced the expansion of the PolarCath peripheral dilatation system product line with the launch of 11 versions of the 0.035-inch guidewire-compatible balloon catheters, which are manufactured by NuCryo Vascular LLC.
In November 2014, Vascular Solutions announced an agreement with NuCryo to serve as the exclusive United States distributor of the PolarCath product line. In March 2015, Vascular Solutions launched 21 versions of the 0.014-inch guidewire-compatible balloon catheters for use with the PolarCath system.
According to Vascular Solutions, the PolarCath peripheral dilatation system is indicated for use in dilating stenoses 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 fistulas. The PolarCath system is also indicated for postdeployment stent expansion of self-expanding peripheral vascular stents.
The company stated that the PolarCath peripheral dilatation system consists of a balloon catheter, an inflation unit, and a nitrous oxide cartridge. Use of the PolarCath system simultaneously dilates and modifies atherosclerotic plaque. After it is delivered to the lesion, the PolarCath balloon is inflated with nitrous oxide gas, which cools the vessel wall during a 20-second treatment at -10°C.
The PolarCath peripheral dilatation system was invented by interventional cardiologist James Joye, MD, who is the Director of Research and Education of the Norma Melchor Heart & Vascular Institute at El Camino Hospital and Cofounder of NuCryo.
In the Vascular Solutions press release, Dr. Joye commented, “Balloon cryoplasty has been shown in clinical studies and in everyday practice to be an important option for treating peripheral arterial disease. Some of the strongest clinical support for PolarCath to date has come from the COBRA study, a randomized controlled clinical trial that demonstrated that balloon cryoplasty is an excellent postdilatation strategy in stent placement in the superficial femoral artery. I am pleased that the availability of a wide range of 035 PolarCath balloon catheters will allow colleagues to refocus on this important area of practice.”