July 30, 2008 - Having completed clinical trials of its ThromboGuide (T-Guide) Platelet aggregation system, ThromboVision Inc. has filed a 510(k) market clearance review application with the FDA.
Clinical trial data were gathered through independent studies at four research facilities - The Methodist Hospital Research Institute, Houston; University of Arizona, Tucson; Intermountain Medical Center, Salt Lake City; and Houston Institute for Clinical Research. The principal investigators at the sites were Drs. Neal Kleiman, Marvin Slepian, Jeffrey Anderson, and Dale Halter, respectively.
With nearly 50 million patients on medications like aspirin and clopidogrel (Plavix) to modify the aggregability of their platelets, the company said it is anxious to be able to offer the new technology to treat patients for heart attacks, strokes, and stents occlusion prevention.
The T-Guide consists of a disposable test kit and a point-of-care base unit. The system will help physicians assess an individual patient’s anti-platelet therapy used to prevent heart attacks, strokes and stent occlusions.
For more information: www.thrombovision.com