News | January 09, 2008

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

Related Content

clinical trial study antiplatelet thomas jefferson cath function monitors
News | December 12, 2013
Thomas Jefferson University researchers discovered that the formation of blood clots follows a different molecular...
antiplatelet therapy clinical trial blood test platelet function corgenix
News | November 15, 2013
study conducted in Ireland found that...
Feature | November 14, 2013
Professional cardiovascular societies and many working cardiologists question the U.S. Food and Drug Administration’s (...
News | September 23, 2013
Aggredyne Inc., has received ISO 13485 certification for its quality control program related to the manufacture of the...
News | September 05, 2013
September 5, 2013 — ITC Nexus Holding Co., a company in hemostasis management and point-of-care (POC) testing,...
News | July 22, 2013
T2 Biosystems announced the presentation of data strongly correlating T2Hemostat results with patients’ clinical...
Clinical Study Aspirin Duke Medicine Blood Test Platelet Functioning Testing
News | July 12, 2013
Aspirin has been widely used for more than 50 years as a common, inexpensive blood thinner for patients with heart...
cath lab, SYNTAX, SCAI
Feature | July 03, 2013 | Dmitriy N. Feldman, M.D., FACC, FSCAI
The year 2013 has brought us several important clinical trials that have changed the way interventional cardiologists...
UK Blood Clots Teststing Wafarin Self Monitoring
News | April 29, 2013
A simple self-monitoring test could reduce the risk of stroke by half in thousands of people in the United Kingdom who...
Overlay Init