Philips, MediGuide initiate cardiac navigation clinical trials
Philips and MediGuide have started planned clinical trials in the U.S. at Columbia New York Presbyterian Hospital under IDE using the Philips Integris Allura Flat Detector catheterization lab integrated with MediGuide's Medical Positioning System (gMPS) technology and using the MediGuide gMPS-enabled guided measurement catheter (GMC).
Royal Philips Electronics and MediGuide in Haifa, Israel, have been cooperating since 2003 in the field on cardiac navigation. The gMPS system and the GMC device are CE Mark certified and are limited to investigational use in the U.S., Philips said.
The gMPS is intended for intravascular evaluation of coronary anatomy and for use as an adjunct to coronary angiography. It is intended to enable real-time tip positioning and navigation of a gMPS-enabled (equipped with an gMPS sensor) diagnostic or therapeutic invasive device used in coronary or cardiac intervention in the cath lab environment, on either live fluoroscopy or recorded background, MediGuide said.
The gMPS-enabled GMC intravascular device is intended to be used in conjunction with conventional x-ray angiography systems to enable real-time tip positioning and navigation, quantitative length measurement, 3D lumen reconstruction, qualitative 3D foreshortening indication and landmarking, in patients who are candidates for coronary angiography and/or percutaneous coronary intervention, according to Philips.