Vascular Solutions Announces 510(k) Clearance of Twin-Pass Catheter and U.S. Launch of Pronto V3
MINNEAPOLIS, Dec. 1 - Vascular Solutions, Inc. (NASDAQ:VASC) today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration to launch the Twin-Pass(TM) dual access catheter. The Twin-Pass is a two lumen catheter designed to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral arterial vasculature and for use during procedures utilizing two guidewires. The company expects to launch the Twin-Pass catheter through its direct U.S. sales force in January.
The company also announced today that it has commenced the launch of the V3 version of the Pronto(TM) extraction catheter in the U.S. through is direct sales force and in Europe through its independent distributor network. The V3 improvements include a full length wire braid and hydrophilic coating for ease of deliverability and enhanced performance. The Pronto V3 catheter is designed for the mechanical aspiration removal of acute thrombus from the arterial system.
"The initial cases that have been performed with the new V3 in November demonstrated excellent clinical results," commented Howard Root, Chief Executive Officer of Vascular Solutions. "While the changes in the design of the catheter appear minor, in terms of performance our customers are noticing a major improvement with the V3 that we believe will result in the Pronto becoming our fastest growing product line in 2006. In addition, the clearance and pending launch of the clinically-unique Twin-Pass catheter should be a material addition to our sales starting in the first quarter of 2006. This strategy of focusing on underserved clinical opportunities and developing unique solutions continues to result in rapid growth and an expanding product portfolio within Interventional medicine," Mr. Root added.
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. New products introduced since the second half of 2003 include the Vari-Lase(R) endovenous laser product line for the treatment of varicose veins, the D-Stat Dry(TM) hemostatic bandage for the rapid control of topical bleeding, the Pronto extraction catheter for the mechanical extraction of soft thrombus and the Langston(TM) dual lumen catheter for the measurement of aortic stenosis. The Company's other major products include the Duett(TM) sealing device to rapidly seal the puncture site following catheterization procedures and the DStat(R) Flowable hemostat for the local management of active bleeding.
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, 2004 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 www.vascularsolutions.com/ .
Source: Vascular Solutions, Inc.
CONTACT: Howard Root, CEO, or James Hennen, CFO, both of Vascular Solutions, Inc., +1-763-656-4300
Web site: www.vascularsolutions.com/
