Medical Ventures Corp.
TSX VENTURE : MEV
October 04, 2007 17:01 ET
Medical Ventures Submits Second PMA Module to FDA
Company seeking U.S. approval of Metricath Gemini device
RICHMOND, BRITISH COLUMBIA--(Marketwire - Oct. 4, 2007) - MEDICAL VENTURES CORP. (TSX VENTURE:MEV) has submitted to the U.S. Food and Drug Administration the second of three modules of its pre-market approval (PMA) application for the Metricath Gemini® catheter. The FDA will review the modules to determine whether the Gemini device will be approved for use in coronary arteries in the United States.
The latest module to be submitted contains information related to the Metricath Gemini's performance in laboratory and animal testing. Medical Ventures submitted the first module, outlining product manufacturing information, in August 2007. Contents of the first two modules are based on existing data that previously yielded regulatory approvals for the Metricath Gemini in Europe and Canada. A third module, based largely on information from the multi-centre GAAME clinical trial, is expected to be submitted by year-end.
About Metricath Gemini®
The Metricath Gemini is a dual-balloon catheter system used during angioplasty procedures to treat heart and vascular disease. The catheter features a low-pressure balloon to measure within arteries and stents, helping doctors confirm stent selection and expansion for optimal treatment outcomes. The Metricath Gemini also features a high-pressure angioplasty balloon that can be used to expand vessels or under-deployed stents by inflating the balloon within the artery.
About Medical Ventures Corp.
Medical Ventures Corp. develops, manufactures and markets medical devices for the quickly growing vascular and surgical marketplace. MEV products help doctors treat a wide range of health concerns, including vascular disease and obesity. MEV products include the Metricath® vascular measurement system and PeriPatch™, a line of surgical tissue products. Medical Ventures is also a contract medical devices manufacturer. For more information, please visit: www.medical-ventures.com.
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