Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
Ischemia diagnostic study: Cambridge Heart has initiated a 200-patient study to evaluate microvolt T-wave alternans testing in detection of ischemia in patients with known or suspected coronary artery disease, the firm announced July 6. The company is hoping to show that MTWA, which allows real-time intra-cardiac measurements of heart rhythm irregularities, can enhance the diagnosis of underlying ischemia; currently, the test, conducted on its HearTwave II system, is used to assess the risk of potentially fatal arrhythmias. Enrollment in the trial is expected to wrap up in mid-2011. "If the results of the pilot study confirm our finding, we will begin a larger study [in] the second half of 2011," according to Cambridge Heart CEO Ali Haghighi-Mood. The firm announced it had licensed the patent for the incorporation of MWTA in implantable medical devices from MIT in 2008 (1"The Gray Sheet" June 30, 2008)
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Research In Brief
SynCardia heart portable driver: Company has received conditional IDE approval to begin a study of its Freedom portable driver to power the CardioWest total artificial heart in bridge-to-cardiac-transplant patients. The trial, which will enroll 60 subjects, aims to demonstrate that stable CardioWest patients can manage their portable driver outside the hospital. According to SynCardia, a "major drawback" of existing technology is that patients are attached to a 418-pound driver and confined to the hospital while they await transplant. By contrast, the Freedom driver weighs 13.5 pounds and would enable patients to resume normal activities while awaiting a transplant, the firm says. The study will follow patients until transplant, 90 days after discharge, 90 days of Freedom support in the hospital or death. The Freedom driver received CE mark approval for use in Europe March 1