ThromboVision Intiates Clinical Trials on Platelet Function Monitor
January 10, 2008 - ThromboVision Inc., a biomedical diagnostics company, has initiated clinical trials of its ThromboGuide (T-Guide) Platelet Function Monitor. Enrollment and data collection are under way at four key research institutes as it prepares to apply for 510(k) FDA clearance.
The T-Guide consists of a disposable test kit and a point-of-care base unit. The system is designed to help physicians individualize antiplatelet therapy that they use to prevent heart attacks, strokes and stent occlusions.
The company expects these clinical studies to provide the foundation for its 510(k) application to the FDA to market the device and a CLIA waiver to enable nontechnical staff to run the tests in settings such as physicians' offices and clinics.
The facilities and principal investigators are:
* The Methodist Hospital Research Institute, Houston – Neil S. Kleiman, M.D., medical director, Cardiac Catheterization Laboratories, The Methodist DeBakey Heart Center, The Methodist Hospital and The Methodist Hospital Research Institute; professor of medicine, Weill Medical College, Cornell University
* University of Arizona, Tucson – Marvin J. Slepian, M.D., clinical professor of medicine; director of interventional cardiology, The University of Arizona College of Medicine
* LDS Hospital (Intermountain Healthcare), Salt Lake City – Jeffery L. Anderson, M.D., associate chief of cardiology, LDS Hospital; co-director of cardiac research and professor of internal medicine, University of Utah; chair, ThromboVision scientific advisory board
* Houston Institute for Clinical Research, Dale Halter, M.D., co-director.
ThromboVision has licensed the patented technology developed by scientists affiliated with the Utah Artificial Heart Institute, Brigham Young University and the University of Utah.
For more information: www.thrombovision.com