FDAnews
www.fdanews.com/articles/75324-fda-clears-metricath-gemini-balloon-catheter

FDA CLEARS METRICATH GEMINI BALLOON CATHETER

August 12, 2005

Cardiovascular medical devicemaker Medical Ventures said its Angiometrx division has received FDA 510(k) clearance for the Metricath Gemini Balloon Catheter for peripheral artery procedures, allowing the device to be sold and marketed in the U.S.

The Metricath Gemini dual balloon catheter combines the Metricath arterial measurement technology with the treatment capability of a high-performance angioplasty balloon. Using the device, physicians can precisely measure arterial size and stent deployment, and dilate a vessel using a single, cost-effective catheter. The catheter is designed for use in patients who have been diagnosed with peripheral arterial disease -- caused by a fatty build-up in the artery that blocks normal blood flow.

The Metricath Gemini will be introduced into the peripheral market in the U.S. during the fourth quarter of this year, said Medical Ventures. Clinical trials for the U.S. approval of the Metricath Gemini in coronary arteries will begin shortly, with FDA approvals expected in late 2006.

(http://www.fdanews.com/ddl target=_blank)