FDAnews Device Daily Bulletin

TOPSPIN MEDICAL GETS FDA APPROVAL TO START CLINICAL TRIALS IN THE US AND COMPLETES THE DEVELOPMENT OF A PROTOTYPE OF ITS ADVANCED GENERATION INTRAVASCULAR MRI (IVMRI) CATHETER

July 10, 2006
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TopSpin Medical announced it has received FDA approval to start conducting clinical trials in the US with its IntraVascular MRI (IVMRI) catheter, intended for the characterization of lipid-rich lesions in the coronary arteries. TopSpin IVMRI catheter technology enables MRI to be performed in the clinic for the first time with no external magnets. To date the company 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 leading US clinical sites.

Genetic Engineering News (http://www.genengnews.com/news/bnitem.aspx?name=3171975)