Medical Ventures Completes U.S. FDA Application For Metricath Gemini

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 26 Nov 2007 - 15:00 PDT

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Medical Ventures Corp. (TSXV: MEV), a medical devices company specializing in products for the vascular and surgical markets, has completed filing of its pre-market approval (PMA) application to the U.S. Food and Drug Administration for its Metricath Gemini® catheter system. The company has submitted the third and final module of a three-module submission. FDA approval will permit doctors performing angioplasty in the United States to use the Metricath Gemini device to measure and treat diseased coronary arteries.

This third application module contains required data from the company's GAAME (Gemini Angioplasty and Arterial Measurement Evaluation) clinical trial, which investigated the safety and efficacy of the device in clinical use. The FDA is also reviewing two additional modules the company submitted previously, which contain information related to manufacturing and animal and laboratory testing.

GAAME trial data highlights

The GAAME trial data report submitted to the FDA suggests that the Metricath Gemini system is safe for its intended use, with a major adverse cardiac event (MACE) rate of 2.7% observed during the trial, which is in the range of the rate typically expected for coronary angioplasty procedures. The study also demonstrated that the Metricath Gemini system functions as intended when used to pre-dilate a lesion, post-dilate a stent or take measurements within the native or stented artery.

Medical Ventures' president and chief operating officer, Alexei Marko, said: "We are excited to have completed this final submission to the FDA, as this application is a critical milestone for our company. Seeing that the Gemini has shown a high rate of success for dilation of the artery or implanted stents, along with a low incidence of adverse events, leads us to anticipate a positive FDA response on the coronary use of Gemini."

About GAAME

The GAAME trial (for Gemini Angioplasty and Arterial Measurement Evaluation) is a prospective, non-randomized, multi-centre study evaluating the Gemini device's safety and efficacy when used to pre-dilate a lesion or post-dilate a stent in the coronary artery. The trial's primary end-point objectives were: 1) freedom from major adverse coronary events at 30 days, and 2) device success as determined by residual diameter stenosis.

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-expanded 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.

http://www.medical-ventures.com