Cambridge Heart Takes A Step Towards Implantable Cardiac Device Market
This article was originally published in The Gray Sheet
Executive Summary
Microvolt T-wave alternans test maker Cambridge Heart signaled interest in moving more squarely into the implantable cardiovascular device market June 23
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Research In Brief
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)
Research In Brief
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)
Research In Brief
Inconsistent disclosures in stent studies: Authors did not disclose any financial ties to industry in 83% of scientific articles on coronary stents in 2006, according to a survey of 746 articles in 135 journals published by researchers at the Duke Clinical Research Institute. According to the survey results, appearing in the May issue of PlosOne, only 6% of the 2,985 authors credited in the surveyed articles disclosed a relationship in an article, and of the 75 authors who disclosed at least one financial relationship, only 2 (3%) disclosed that relationship in every article they wrote. Sixteen authors (26 articles total) disclosed a financial relationship in one article but declared they had no financial interests in another article. The survey is the first to examine the consistency of authors' disclosures in biomedical literature, Kevin Weinfurt, et al, say. "It could be argued that an inconsistent system of disclosure is more harmful than no disclosure at all," the author's argue. "The current approach creates the impression rather than the reality of transparency and may encourage underestimation of the impact of conflictions of interest on the integrity of medical science.