A device that uses light-scattering technology to determine platelet aggregation in cardiac patients is now heading out to make its way through the regulatory process.

With its clinical trials of ThromboGuide (T-Guide) platelet aggregation system completed, ThromboVision (Houston), a diagnostics company, said it has filed a 510(k) application with the FDA for clearance of the system.

The T-Guide consists of a disposable test kit and a point-of-care base unit. According to ThromboVision, the system is designed to help physicians improve their cardiac patients' lives by providing additional information as they assess an individual patient's anti-platelet therapy used to prevent heart attacks, strokes and stent occlusions.

"In layman's terms, it allows us to measure the level of stickiness of platelets," Edward Teitel, MD, president/CEO of ThromboVision, told Medical Device Daily.

Last year the company was awarded $1.5 million from the Texas Emerging Technology Fund to foster commercialization of the T-Guide system (Medical Device Daily, Oct. 15, 2007), and in January it initiated clinical trials of the technology (MDD, Jan. 14, 2008).

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 respective sites were Drs. Neal Kleiman, Marvin Slepian, Jeffrey Anderson, and Dale Halter.

"With nearly 50 million patients on medications like aspirin and clopidogrel [Plavix] to modify the aggregability of their platelets, we are anxious to be able to offer our technology to doctors who treat patients for heart attacks, strokes, and stents occlusion prevention," Teitel said.

He said ThromboVision's 510(k) application is the culmination of research that began at the Utah Artificial Heart Institute (Salt Lake City), Brigham Young University (Provo), the University of Utah (Salt Lake City) and Thrombodyne (Salt Lake City) in 1998 and was then supported by multiple grants from the National Institutes of Health.

"After obtaining the worldwide, exclusive rights to the technology, ThromboVision did a great deal of design and engineering work to advance it to this point," Teitel said. "We are hopeful that when the FDA reviews our data and other materials, they will respond positively."

Teitel told MDD that the company anticipates the test will be cleared and on the market later this year.

"We're just excited to be able to bring a potential lifesaving technology to the market in a way that's cost effective and simple to use," he said.

At least two other private device companies are also addressing the need for a simple point-of-care, CLIA-waived, rapid test for measuring platelet reactivity.

Accumetrics (San Diego) introduced the first simple system for measuring individual response to multiple anti-platelet agents, including aspirin, Plavix, ReoPro and Integrilin. It has the only FDA-cleared, CLIA-waived, point-of-care test that measures whether a drug has blocked a specific pathway to platelet activation by using a specific cartridge for each drug tested (MDD, April 8, 2008).

Another company, Placor (Plymouth, Minnesota), is testing the platelet reactivity using shear force, mimicking a stenotic artery, rather than using a specific agonist that tests for a certain pathway of inactivation.

The company's theory is that it is testing the actual ability of the platelet to aggregate, regardless of whether anti-platelet drugs are being used, eliminating the need to test for each drug prescribed to the patient. Placor's testing system requires only a fingerstick rather than a venipuncture, and the company expects FDA clearance and initial commercialization this quarter, followed by application for CLIA waiver. The test takes only 10 minutes.