Tewksbury, MA-based Cambridge Heart has concluded a review of data generated at several clinical sites indicating its Microvolt T-Wave Alternans test is a statistically significant predictor of ischemic events. The data also revealed instances in which the test identified underlying coronary artery disease not uncovered by other standard diagnostic modalities.
The study has given the company the required information for a prospective clinical trial to provide the basis for regulatory approval. Cambridge Heart has concluded the enrollment in its MTWA-CAD study and started the design of the prospective clinical trial.
Company CEO Ali Haghighi-Mood told FierceMedicalDevices the test is important because it can help identify patients who might later experience ischemic events, as well as those at risk of sudden cardiac arrest. He added the patient population for moderate to high risk coronary artery disease is roughly 30 million to 40 million in the U.S. alone.
"Our objective is to improve the detection of coronary artery disease by having MTWA measured in conjunction with other read-out modalities such as ECG, ultrasound imaging or nuclear imaging during stress testing. We intend to pursue the additional clinical trial required for regulatory approval as aggressively as possible," he said in a statement.
- see the Cambridge Heart release