Vascular Solutions Expands Launch of PolarCath(TM) System With 0.035” Catheters

MINNEAPOLIS,  Vascular Solutions, Inc. today announced that it has expanded the PolarCath peripheral dilatation system product line with the launch of 11 versions of 0.035” guidewire-compatible balloon catheters in collaboration with NuCryo Vascular LLC, the manufacturer of the product. 

As previously announced, Vascular Solutions entered into an agreement with NuCryo in November of 2014 to serve as the exclusive U.S. distributor of the PolarCath product line and in March of this year Vascular Solutions launched 21 versions of 0.014” guidewire-compatible balloon catheters for use with the PolarCath system.

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 (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath system is also indicated for post-deployment stent expansion of self-expanding peripheral vascular stents.

“PolarCath has an important role in the treatment of peripheral arterial disease, as reflected by more than a decade of solid clinical experience showing strong outcomes in both above- and below-the-knee procedures,” commented Howard Root, Chief Executive Officer of Vascular Solutions. “The previous launch of the 0.014” guidewire-compatible PolarCath balloon catheters allowed us to focus mainly on the needs of physicians treating below-the-knee cases. Today’s launch of the 0.035” guidewire-compatible catheters completes our portfolio of PolarCath balloon catheters and will allow us to target above-the-knee interventions.”

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. Once 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 Dr. James Joye, a prominent interventional cardiologist focused on pioneering new vascular treatments.

“Balloon cryoplasty has been shown in clinical studies and in everyday practice to be an important option for treating peripheral arterial disease,” Dr. Joye said. “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 post-dilatation 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 re-focus on this important area of practice.”

Source:  Vascular Solutions