Heartwave II
This article was originally published in The Gray Sheet
Executive Summary
FDA clears Cambridge Heart's third-generation Microvolt T-wave Alternans sudden cardiac death risk diagnostic system, the firm says April 11. Unlike previous versions of the system, Heartwave II can complete all of the elements of a MTWA test and does not require a host stress exercise system to control the treadmill during the stress-test portion of the diagnostic procedure. Medtronic is co-sponsoring an MTWA registry to help determine whether the test can identify post-MI heart failure patients most likely to benefit from an implantable cardioverter defibrillator (1"The Gray Sheet" July 14, 2003, p. 32)...