October 6, 2011 – Cambridge Heart Inc. announced it has concluded data review for the company’s microvolt T-wave alternans-computer-aided detection (MTWA-CAD) feasibility study. The data suggest MTWA is a statistically significant predictor of ischemic events. In addition, the data revealed instances where the company's MTWA test identified underlying coronary artery disease that was not identified by other standard diagnostic modalities.
Commenting on the data, Richard Cohen, M.D., chairman of the company’s Scientific Advisory Board and Whitaker professor in biomedical engineering at the Massachusetts Institute of Technology, stated, “The results of the review are very promising, suggesting that microvolt T-wave alternans is predictive of ischemic events in cardiac patients undergoing routine stress testing.”
The feasibility study provided Cambridge Heart with the information required to design a multi-center, prospective clinical trial intended to provide the basis for regulatory approval. Accordingly, the company has decided to conclude the enrollment in its MTWA-CAD study, and commence design of the prospective clinical trial.
For more information: www.cambridgeheart.com