St. Jude Medical Begins US Trial Studying ST Segment Monitoring Technology

St. Jude Medical, Inc. STJ today announced that the first patient in a clinical study examining the safety and effectiveness of an ST segment monitoring feature in an implantable cardioverter defibrillator has been implanted with the investigational device in the United States. The ST Monitoring to Detect ACS Events in ICD Patients study will evaluate effectiveness of the feature in the Fortify ST ICD by analyzing its accuracy in detecting acute coronary events, such as myocardial infarction, commonly known as a heart attack. Dr. Scott Allison and Dr. Paul B. Tabereaux of Heart Center, Inc. at Huntsville Hospital in Alabama implanted the first two patients in the trial. Commenting on the study, Dr. Allison said, "When a patient is experiencing a heart attack, every minute counts. For every 30 minutes that treatment is delayed, mortality increases by 7.5 percent. Because symptoms can be vague, and approximately one-third of patients don't even have typical chest symptoms, the average time it takes for a patient to seek treatment has remained at almost 3 hours over the last decade. We hope the device being studied in the Analyze ST trial can help provide physicians with more information about coronary events that will allow us to intervene and provide treatment earlier." The ST segment is a section of an electrocardiogram that depicts electrical changes between heartbeats. Changes in ST segments have long been studied in clinical settings using external devices as indicators for an obstruction of blood flow and oxygen to the heart muscle (cardiac ischemia). However, due to several limitations, it has not been practical to study them on a continual basis. A method to monitor the ST segment without such limitations could provide important insights into the overall clinical assessment of patients at risk for coronary events. Monitoring for ST changes within the heart of an ambulatory patient may provide unique insight into the presence and severity of changes of the ST segment and occurrence of ischemia in patients with coronary artery disease. 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 approval from the U.S. Food and Drug Administration 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.