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Vascular Solutions Announces FDA 510(k) Clearance of Zigiwire(TM) Access Guidewire System

  • Vascular Solutions will distribute two models of the ZigiWire guidewire system, a novel support wire system designed for gaining vascular access in both simple and challenging peripheral intervention
  • ZigiWire is developed and manufactured by VadisWire Corp.
  • Vascular Solutions expects U.S. launch of ZigiWire in January

MINNEAPOLIS, Dec. 19, 2014 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the ZigiWire access support guidewire system has received FDA 510(k) clearance. ZigiWire is designed to facilitate placement and exchange of catheters during peripheral diagnostic or interventional procedures. Vascular Solutions plans to launch ZigiWire through its 101-member direct U.S. sales force in January 2015.

ZigiWire is manufactured for Vascular Solutions by VadisWire Corp., a Kirkland, Washington-based company founded by interventional cardiologist William Gray, M.D., and by veteran medical device industry engineer and executive Ted Wulfman.

The ZigiWire guidewire support systems employ a novel method of establishing progressive and secure support wire access into most arterial vascular anatomy in an efficient and time saving manner. Through any standard 0.038" compatible catheter lumen, the operator advances a floppy-style lead wire for initial engagement of the target vessel which is then followed by up to two additional wires to achieve the desired level of guidewire support.

"By delivering small diameter wires consecutively into the peripheral vasculature, ZigiWire allows an operator to more easily access the intended vessel," said Dr. Gray, from the Cardiovascular Research Foundation. "Several small wires in parallel provide the cable-type support required to deliver a range of larger sheaths and guiding catheters into challenging anatomy such as in the lower extremities and mesenteric vasculature."

Vascular Solutions will offer two versions of ZigiWire, consisting of a two-wire version and three-wire version. The two-wire version is designed for use in contralateral access cases in lower extremity vasculature. The three-wire version is designed to provide extra support in other peripheral anatomy procedures such as gaining access into mesenteric or other vasculature that is tortuous in nature.

"As part of our commitment to serving the needs of interventional physicians who perform peripheral procedures, we are very pleased to be adding ZigiWire to our lineup of important clinical solutions," said Howard Root, Chief Executive Officer of Vascular Solutions. "We are excited to be collaborating with Dr. Gray and Ted Wulfman in bringing this novel device to the market."

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: Phil Nalbone, VP Vascular Solutions, Inc. pnalbone@vasc.com (763) 656-4371Source:Vascular Solutions, Inc.