TEL AVIV, Israel /PRNewswire-FirstCall/ -- TopSpin Medical announced it has received FDA approval to start conducting clinical trials in the U.S. 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 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 leading U.S. sites.
In addition, TopSpin Medical announced it has completed the development of a prototype of its advanced generation IVMRI catheter, in accordance with the planned schedule. This advanced generation IVMRI catheter prototype is a further technological breakthrough in the miniaturization of the sensors and in the ability to integrate a number of sensors for imaging longer arterial segments in a short acquisition time.
The company projects that it will receive marketing clearance in Europe (CE Mark) by the end of 2006 and aims to receive marketing clearance in the U.S. by the middle of 2007.
"We're encouraged by the technological breakthrough achieved in the development of our advanced generation IVMRI catheter," said Erez Golan, TopSpin Medical's president and CEO. "The completion of the advanced prototype development in parallel to substantial progress in our clinical trials will enable us to get the marketing clearance and launch the IVMRI catheter in Europe and in the U.S. as planned. Subsequently, we will be able to offer cardiologists advanced generations of the IVMRI catheter using the same imaging console."