MINNEAPOLIS, July 3, 2007 (PRIME NEWSWIRE) -- Vascular Solutions, Inc. (NasdaqGM:VASC - News) today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration to launch the Gopher(tm) support catheter in the United States. The Gopher catheter is designed to assist in the passage of interventional devices through arterial lesions by utilizing a unique rotational force. The Gopher catheter will be available in both 3 French and 2 French sizes and is part of Vascular Solutions’ specialty catheter product line. Initial clinical evaluations of the Gopher catheter have already occurred, and a launch of the Gopher catheter through Vascular Solutions’ 80+ employee direct U.S. sales force is expected to commence in the third quarter.
Dr. J. Aaron Grantham, an Interventional cardiologist with the Med America Heart Institute at St. Luke’s Hospital in Kansas City, Missouri, performed the first clinical evaluation of the Gopher catheter following Vascular Solutions’ receipt of 510(k) clearance. Dr. Grantham commented: ``The Gopher catheter was designed to facilitate the passing of an angioplasty balloon in challenging coronary interventions, a problem I frequently encounter. In the case I performed with the device, it was easy to use and performed beautifully. I will definitely continue to use the Gopher catheter in my difficult interventions.’'
Howard Root, Chief Executive Officer of Vascular Solutions, commented: ``The Gopher catheter is another addition to our line of internally-developed specialty catheters designed to meet specific needs of physicians performing interventional percutaneous procedures in coronary and peripheral arteries. While the commercial success of the Gopher catheter will require the customary clinical demonstrations, we believe that over time the Gopher catheter has the potential to become at least a $10 million product within our rapidly-growing specialty catheter product line.’'
About Vascular Solutions
Vascular Solutions, Inc. is a medical device company that focuses on developing unique solutions for unmet clinical opportunities within interventional radiology and interventional cardiology. The company’s five main product categories consist of hemostat (blood clotting) products, extraction catheters, vein products, specialty catheters and access products. New products introduced since the second half of 2003 include the D-Stat Dry(tm) hemostatic bandage for the rapid control of topical bleeding, the Pronto(tm) extraction catheter for the aspiration of soft thrombus, the Langston(r) dual lumen specialty catheter for the measurement of aortic stenosis, the Vari-Lase(r) endovenous laser product line for the treatment of varicose veins, and the Twin-Pass(r) dual access specialty catheter for dual wire access in interventional procedures.
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, 2006 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, limited working capital, lack of profitability, exposure to intellectual property claims, dependence on key vendors, exposure to possible product liability claims, the development of new products by others, doing business in international markets, limited manufacturing experience, the availability of third party reimbursement, and actions by the FDA.
For further information, connect to http://www.vascularsolutions.com.
Contact: Vascular Solutions, Inc. Howard Root, CEO James Hennen, CFO (763) 656-4300
Source: Vascular Solutions, Inc.
