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Posted on 02.05.01
Duke CERTs: Following New Devices into the "Real World"
By Judith M. Kramer, MD
The public, health practitioners, and U.S. Food and Drug Administration (FDA) staff are increasingly concerned that the safety of devices newly approved by the FDA may differ from that shown in the small studies leading to their approval. The Duke CERTs is using a new approach to study this: answering the question by tapping into information gathered by a medical society. In this case, the Duke Research Center is collaborating both with the Society of Thoracic Surgeons (STS), in using their National Cardiac Surgery Database, and with 3 FDA investigators to address an important safety concern.
For example, the FDA recently approved a laser heart treatment, commonly referred to as TMR (transmyocardial revascularization). This device is targeted for patients who have severe chest pain, called angina, resulting from reduced blood flow to the heart's muscle cells. The laser is intended for patients with angina who are not candidates for typical procedures to open up the heart's arteries (balloon angioplasty or stent procedures). The newly approved device uses a laser to drill tiny holes in the heart muscle itself.
There are several ideas about how this method might help patients with severe angina. The tiny channels created by the laser may provide blood directly to the heart muscle. Alternatively, the laser treatment may stimulate the growth of new, tiny blood vessels that would supply blood to the heart muscle. It also may interrupt the nerve supply to the heart muscle, reducing the pain, or kill off the muscle cells suffering from a lack of blood.
STS, a professional society of heart and chest surgeons, collects data continuously from about 500 U.S. medical centers performing heart surgery. In this research collaboration, STS is partnering with the FDA and with Duke University, which serves as the data warehouse for STS. In this study, a subset of 53 participating TMR sites are collecting a little more data than usual--the specific device used, for example, and the outcome of the procedure.
The Duke Research Center hopes that this approach will become a new model for the future of community-based research: the collaboration of a national medical society with the FDA and academic researchers to answer important questions about the safety of new devices.