Sept. 4, 2012 — Medtronic has reached two clinical program milestones for its CoreValve transcatheter aortic valve system in the United States. It completed enrollment in its study of high-risk patients in its CoreValve U.S. Pivotal Trial, which concludes the total trial enrollment of more than 1,500 patients with severe aortic stenosis who are at high- or extreme-risk for aortic valve surgery. Medtronic continues to enroll extreme-risk patients in the trial as part of the U.S. Food and Drug Administration (FDA) continued access policy and is seeking approval to continue enrolling high-risk patients under this policy.
In addition, Medtronic received FDA conditional approval to begin evaluating the CoreValve System in patients at intermediate risk for open-heart aortic valve replacement as part of the Medtronic CoreValve Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) Trial. U.S. patient enrollment is expected to begin within weeks.
“With a sizeable population of Americans with severe aortic stenosis who have varying degrees of risk for open-heart aortic valve replacement surgery, the CoreValve U.S. Pivotal Trial and SURTAVI Trial are landmark trials that will provide critical insights about the appropriate use of the self-expanding CoreValve System,” said David H. Adams, M.D., chair of the department of cardiothoracic surgery at The Mount Sinai Medical Center and national co-principal investigator of both the CoreValve U.S. Pivotal Trial and SURTAVI Trial. “We are optimistic and eager to fulfill the requirements of both trials with the goal of effectively demonstrating the value of CoreValve as an alternative to open-heart valve replacement surgery.”
The CoreValve U.S. Pivotal Trial has enrolled more than 1,500 patients in two studies (high- and extreme-risk) led by heart teams made up of interventional cardiologists and cardiac surgeons at 45 leading clinical institutions across the United States. Approximately two-thirds of trial patients are in the high-risk study. The primary endpoint for the high-risk study is freedom from all-cause death at 12 months, and the primary endpoint for the extreme risk study is freedom from all-cause death or major stroke within 12 months.
The SURTAVI Trial is the largest global, randomized, controlled trial on transcatheter aortic valve implantation (TAVI) and will evaluate approximately 2,500 patients. The trial will evaluate the potential for the minimally invasive CoreValve system to be considered for less-sick patients who typically are treated with open-heart surgical aortic valve replacement today (SAVR). Within the SURTAVI Trial, CoreValve implantation can be performed by transfemoral, subclavian or direct aortic access, depending on the needs of the patient. Selection of intermediate risk surgical patients will be based on the Society of Thoracic Surgeons (STS) mortality risk of ?4 percent and ?10 percent and the study’s primary endpoint will be a composite of all-cause mortality and disabling stroke at 24 months. All patients will be followed through five years. U.S. principal investigators are Adams; Jeffrey Popma, M.D., director, interventional cardiology at the Beth Israel Deaconess Medical Center, Boston; and Michael Reardon, M.D., chief of cardiac surgery at the Methodist DeBakey Heart and Vascular Center, Houston.
Since 2007, the Medtronic CoreValve System has been implanted in more than 30,000 people in more than 60 countries outside the United States.
For more information: www.clinicaltrials.gov