Vascular Solutions has announced that it has commenced sales of the PolarCath peripheral dilatation system in the United States in collaboration with NuCryo Vascular, the manufacturer of the product.
As previously announced, Vascular Solutions entered into an agreement with NuCryo in November 2014 to serve as the exclusive US distributor of the PolarCath product line. Vascular Solutions is projecting between US$3 million to US$5 million in PolarCath sales during 2015.
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.
“With more than a decade of extensive clinical experience, PolarCath has an important role in the treatment of peripheral arterial disease,” commented Howard Root, Chief Executive Officer of Vascular Solutions. “The product is a natural fit for our US direct sales force and our focus on meeting the needs of interventional vascular physicians. Beginning today, we have available the wide range of 0.014” guidewire-compatible PolarCath balloon catheters which target mainly below-the-knee interventions. Later this year, we will add the 0.035” guidewire-compatible versions of the PolarCath balloon catheters which generally 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 James Joye, an 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, which in patients with severe peripheral arterial disease can lead to below-the-knee amputations,” Joye said. “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.”