St. Jude Medical has announced the first patient enrollment for U.S. study of their Fortify ST ICD device, which we have featured previously on Medgadget. The Analyze ST Trial is designed to evaluate the effectiveness of the ST segment monitoring feature of the Fortify ST ICD by assessing its accuracy for measuring acute coronary events such as myocardial infarction.
The advantage of this feature in an ICD is the ability to continuously monitor the ST segment which could provide clinicians with an early warning of an ischemic event.
From the press release:
The Analyze ST trial is a prospective, non-randomized, multicenter, pivotal IDE investigation of up to 5,228 patients at approximately 200 medical centers. St. Jude Medical received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to study the safety and efficacy of the ST segment monitoring feature in the Fortify ST ICD. The sensitivity of the feature for detecting acute coronary syndrome events will be the primary efficacy endpoint. The primary safety endpoint will be assessed by reporting the percentage of patients who experience a false positive detection.
The ST monitoring feature has already received CE marking in Europe and is in use in a number of ST Jude Medical ICDs.