Minneapolis-based Medtronic Inc. (NYSE:MDT) launched a new U.S. study of its Endurant stent graft, used in treatment of abdominal aortic aneurysms.
The device, which is delivered via catheter through the femoral artery, won premarket approval clearance from the FDA in December 2010 and CE Mark approval in the European Union in 2008.
The new trials are post-approval studies designed to test the long-term safety and effectiveness of the device.
St. Paul-based St. Jude launched its own trial, enrolling the first patient in a study of its ST segment monitoring technology, part of an electrocardiogram that displays changes between heartbeats.
St. Jude plans to enroll up to 5,228 patients at approximately 200 medical centers.
"We know that ST segment changes can help us 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," Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical cardiac rhythm management division, said in a press release. "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."
The company’s ST segment monitoring system won CE Mark and has been a part of St. Jude’s ICDs since December 2008.