Seacoast Technologies, Inc. announced today that it has received FDA approval to conduct the first human trial of local hypothermia in brain surgery using its ChillerStrip System. FDA approval of the clinical trial is a major milestone in the rapid development of Seacoast Technologies.
Portsmouth, NH (PRWEB) November 11, 2003 Seacoast Technologies, Inc. announced today that it has received FDA approval to conduct the first human trial of local hypothermia in brain surgery using its ChillerStrip System. The trial will be conducted in patients undergoing repair of a cerebral aneurysm – an area of weakness in a blood vessel in the brain. Cooling provides tissue protection by reducing the metabolism of the brain.
The ChillerStrip system will cool localized areas of the brain to 15ºC (approximately 63ºF).
Dr. Walter Koroshetz, Vice Chairman of the Department of Neurology at the Massachusetts General Hospital, and an innovator of the technology stated We started investigating profound brain hypothermia because of the finding that patients were able to tolerate brain ischemia during temporary cerebral artery occlusion with body temperatures around 20oC. These neurosurgical procedures to repair cerebral aneurysms were done on cardiopulmonary bypass. We believed that local cooling was a means to duplicate this neuroprotection in a safe and controlled manner."
FDA approval of the clinical trial is a major milestone in the rapid development of Seacoast Technologies and represents the culmination of extensive pre-clinical investigations with major medical centers and with Seacoasts engineers and scientists" said Donald J Larnard PhD, President and CEO. During the past three years Seacoast has conducted comprehensive research to demonstrate that hypothermia can be delivered to local areas of the brain safely while cooling significant volumes of brain tissue."
Seacoast Technologies, Inc. was founded in 2000 to serve the neurosurgery and neurointensive care community by offering solutions for neuroprotection through local, profound hypothermia. In addition to the ChillerStrip system, Seacoast is developing a ChillerPad line of products to treat post surgical brain swelling, such as that associated with focal traumatic brain injury or seen postoperatively with other extensive neurosurgeries. A minimally invasive ChillerButton system is also in development which would allow delivery of hypothermia through a burr hole, yet cool significant areas of tissue. These devices have not been cleared for use in the U.S. by the FDA.
For further information, please visit our website at www.seacoasttechnologies.com
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