St Jude Medical has implanted an investigational device in a first patient in a clinical study examining the safety and effectiveness of an ST segment monitoring feature in an implantable cardioverter defibrillator (ICD).
The study is a multicenter, non-randomized, prospective, pivotal IDE investigation trial enrolling 5,228 patients and is designed to assess the safety and efficacy of the ST segment monitoring feature in the Fortify ST ICD by analyzing its accuracy in detecting acute coronary events.
The sensitivity of the feature to detect 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.
St Jude Medical Cardiac Rhythm Management Division research and clinical affairs CMO and senior vice president Mark Carlson said they know that ST segment changes can help them to identify CAD events, so the continuous, internal monitoring that is possible with this technology could provide physicians with an early warning signal that a patient is experiencing an ischemic event.
"Since many patients do not experience symptoms during a heart attack, this technology has the potential to improve the diagnosis and treatment of cardiac ischemia," Carlson said.