Healthcare Industry News: THROMBIGEL
News Release - June 20, 2006
Vascular Solutions Receives Conditional Approval to Commence Thrombin Clinical StudyClinical study to support the use of Thrombin-VSI(TM) in Company's hemostatic devices
MINNEAPOLIS, June 20 (HSMN NewsFeed) -- Vascular Solutions, Inc. (Nasdaq: VASC ) today announced that it has received conditional approval from the U.S. FDA of its Investigational Device Exemption to commence the clinical study of the use of its Thrombin-VSI as a component in the Company's existing hemostatic devices. The clinical study will evaluate the performance of Thrombin-VSI in comparison to the Company's original source of thrombin in use with the Company's Diagnostic Duett Pro(TM) sealing device. The clinical study is also expected to satisfy the clinical requirements necessary for the qualification of the use of Thrombin-VSI in the Company's existing D-Stat Dry(TM), D-Stat Radial(TM), THROMBIGEL® and D-Stat® Flowable hemostats.
"This conditional approval is an important milestone in the qualification of our new source of thrombin to control our long term supply and cost for our hemostatic devices," commented Howard Root, Chief Executive Office of Vascular Solutions, Inc. "The clinical study is expected to commence in the third quarter at up to 10 centers in the United States. We expect to work with the FDA to quickly resolve the conditions of approval, which include clarification of follow-up tests and the refinement of the randomization between study groups, none of which we expect to delay our commencement of the study," 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® 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(TM) extraction catheter for the mechanical extraction of soft thrombus, the Langston® dual lumen catheter for the measurement of aortic stenosis and the Twin-Pass(TM) dual access catheter for dual wire access in interventional cardiology procedures. The Company's other major products include the Duett(TM) sealing device to rapidly seal the puncture site following catheterization procedures and the D-Stat® 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, 2005 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.
Source: Vascular Solutions
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