St. Jude Medical Announces Achievement of Stopping Rule and Closing of Patient Enrollment in RESPECT Clinical Trial

St. Jude Medical, Inc.

today announced that it has met a stopping rule in its RESPECT clinical trial – triggered by reaching the protocol-required number of primary events in the trial, defined as stroke and all-cause mortality – and is closing patient enrollment. “With more than eight years of patient investigation and follow up that includes enrolling 980 patients and collecting more than 2,300 patient-years of data, we're thrilled to announce that we have achieved a significant milestone in our RESPECT trial,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “We're confident in the robust design of our clinical study and in our differentiated product design. We are currently focused on analyzing data from the trial and anticipate presenting results at a major medical meeting sometime in 2012.” The RESPECT trial is a randomized, multi-center study investigating whether closure of the Patent Foramen Ovale (

), a congenital heart defect, using the St. Jude Medical AMPLATZER® PFO Occluder device, is safe and effective compared to current standard-of-care treatment in the prevention of a cryptogenic stroke. A cryptogenic stroke is one for which the origin or cause of stroke is unknown.