Vascular Solutions Receives 510(k) Clearance for Turnpike(TM) Catheters

  • Unique over-the-wire catheters with a proprietary braid and dual-layer coil shaft to provide superior flexibility and torque response
  • Soft Tip version designed to navigate tight curves in tortuous vessels
  • Hard Tip version designed for use in traversing difficult lesions

MINNEAPOLIS, Dec. 1, 2014 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Turnpike catheters, a new line of catheters designed for use in complex coronary and peripheral interventions. Vascular Solutions expects to launch the Turnpike catheters in January following clinical evaluations to occur in December.

"We are excited about the clearance of the Turnpike, which adds to our clinically important tools that started with our GuideLiner catheter for interventional physicians who treat complex cases," said Howard Root, Chief Executive Officer of Vascular Solutions. "We view the Turnpike as one of our most important new product launches for 2015, and we believe this catheter will quickly become a substantial clinical and financial contributor to our product portfolio."

The Turnpike catheters are single-lumen catheters with a shaft constructed from two layers of polymer that encapsulate both a braid and a dual-layer coil. The Turnpike is available in two versions, a Soft Tip and a Hard Tip version, both of which advance over an 0.014" guidewire. The name "Turnpike" describes a unique feature of the catheter that by turning the catheter in a clockwise direction it will advance through the artery (i.e., down the "pike").

The Soft Tip version extends the catheter's braid and dual-layer coil into a soft, radiopaque distal tip which, following a non-tapered polymer-only section, gradually tapers to a smooth distal edge. The Soft Tip version has been designed for use in small and tortuous vessels in which the catheter's flexible tip tracks over the guidewire around tight curves in the artery.

The Hard Tip version terminates with a gold-plated, stainless steel distal tip. The Hard Tip version of Turnpike has been designed for use in cases in which an 0.014" guidewire has advanced through a lesion but the advancement of any other device over the guidewire is difficult. The Hard Tip version is available in two configurations: one with a threaded distal tip designed to provide additional rotational advancement and one with a smooth distal tip for minimal friction during advancement.

The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. The catheters may be used to facilitate placement or exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.

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.

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CONTACT: Phil Nalbone, VP Vascular Solutions, Inc. (763) 656-4371Source:Vascular Solutions, Inc.