MINNEAPOLIS, Nov. 4, 2014 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has entered into an agreement with NuCryo Vascular LLC under which Vascular Solutions will serve as exclusive distributor of the PolarCath Peripheral Dilatation System in the United States.
Vascular Solutions expects to begin sales of PolarCath to customers through its direct U.S. sales force during the first quarter of 2015. Vascular Solutions is projecting between $3 million to $5 million in PolarCath sales during 2015.
The PolarCath Peripheral Dilatation System has FDA clearance to dilate stenosis 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-deployed stent expansion of self-expanding peripheral vascular stents.
“We are very excited to add PolarCath to our broad line of clinical solutions for the treatment of vascular disease,” said Howard Root, Chief Executive Officer of Vascular Solutions. “PolarCath, an FDA cleared device with more than a decade of extensive clinical experience, is an important tool for the treatment of peripheral arterial disease. The product is a natural fit for our U.S. direct sales force and our focus on meeting the needs of interventional physicians.”
The PolarCath Peripheral Dilatation System consists of a disposable catheter, an inflation unit, and a nitrous oxide cartridge. The system is used to perform balloon cryoplasty®, a catheter-based treatment that combines the inflation of a balloon with controlled cooling of the artery. PolarCath is used to dilate peripheral arteries with the same basic technique as balloon angioplasty, except that PolarCath uses nitrous oxide to inflate the balloon rather than liquid. The nitrous oxide cools the balloon to minus ten degrees Celsius, which freezes the built-up plaque in the artery. The PolarCath system was invented by Dr. James Joye, Chief Medical Officer of the Fogarty Institute at El Camino Hospital in Mountain View, CA.
“Balloon cryoplasty has been shown in clinical studies and in everyday practice to be an important option for treating peripheral arterial disease, which can lead to below-the-knee amputations in patients with severe PAD,” 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.”
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.
“We are delighted to have entered into an agreement with Vascular Solutions to bring this one-of-a-kind technology back to the market for the treatment of PAD,” said Richard Lotti, a managing member of the Board of NuCryo Vascular. “We have assembled a talented team at NuCryo to oversee manufacturing and to develop enhancements to an already impressive technology. With Vascular Solutions’ widely-respected sales and marketing capabilities, we are confident that our collaboration will restore PolarCath to a place of prominence in the treatment of PAD.”
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, 2013 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.
CONTACT: Vascular Solutions, Inc. Phil Nalbone, VP-Corp. Dev. PNalbone@vasc.com (763) 656-4371
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