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

MINNEAPOLIS, Aug. 03, 2015 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) 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.”

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 has launched more than 100 products that are sold to interventional cardiologists, interventional radiologists, electrophysiologists, and vein specialists through the company’s 100-employee direct U.S. sales force and international independent distributor network covering 60 countries.

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.

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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.

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Contact: Vascular Solutions, Inc. Phil Nalbone, VP-Corp. Dev. (763) 656-4371

Source:Vascular Solutions, Inc.