TopSpin to start U.S. trials for 'magnet-free' intravascular MRI catheter

By Elaine Rigoli

Tampa, Fla., July 6 - TopSpin Medical has received Food and Drug Administration approval to start conducting clinical trials in the United States with its intravascular MRI (IVMRI) catheter, intended for the characterization of lipid-rich lesions in the coronary arteries.

TopSpin said its IVMRI catheter technology enables MRI to be performed in the clinic for the first time with no external magnets.

To date, the company said it has conducted clinical trials with its IVMRI catheter in more than 70 patients in Europe and Israel, and following the FDA approval, TopSpin intends to extend the clinical trials to U.S. clinical sites.

In addition, TopSpin said it has completed the development of a prototype of its IVMRI catheter, in accordance with the planned schedule.

The company said it hopes to receive marketing clearance in Europe (CE Mark) by the end of 2006 and aims to receive U.S. marketing clearance by the middle of 2007.

TopSpin is a medical products company based in Tel Aviv, Israel.

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