MINNEAPOLIS, March 16, 2015 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has commenced sales of the PolarCath peripheral dilatation system in the United States 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. Vascular Solutions is projecting between $3 million to $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 U.S. 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 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, which in patients with severe PAD can lead to below-the-knee amputations,” Dr. 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.”
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company’s product line consists of more than 80 products in three categories: catheter products, hemostat products and vein products. Vascular Solutions delivers its products to interventional cardiologists, interventional radiologists, electrophysiologists, and vein specialists through its direct U.S. sales force and international independent distributor network.
The information in this press release contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements. Important factors that may cause such differences include those discussed in our Annual Report on Form 10-K for the year ended December 31, 2014 and other recent filings with the Securities and Exchange Commission. The risks and uncertainties include, without limitation, risks associated with the need for adoption of our new products, lack of sustained profitability, exposure to intellectual property claims, significant variability in quarterly results, exposure to possible product liability claims, the development of new products by others, doing business in international markets, the availability of third party reimbursement, and actions by the FDA.
For further information, connect to www.vasc.com
About PolarCath and NuCryo Vascular
The PolarCath system, which received its first FDA clearance in 2002, was developed by CryoVascular, Inc., a company formed by Dr. Joye and collaborators. In 2005, CryoVascular was acquired by Boston Scientific, which discontinued manufacturing PolarCath at the end of 2012. NuCryo Vascular was formed by Dr. Joye and several of the former CryoVascular executives and employees for the purpose of acquiring PolarCath and resuming manufacturing of the device. NuCryo Vascular has established a manufacturing facility for PolarCath in Sunnyvale, CA.
For further information, connect to www.nucryovasc.com
CONTACT: Vascular Solutions, Inc. Phil Nalbone, VP-Corp. Dev. PNalbone@vasc.com (763) 656-4371
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