Medtronic Begins US Enrollment of Intermediate-Risk Patients in Global SURTAVI Trial

November 16, 2012—Medtronic, Inc. (Minneapolis, MN) announced the first treatment of a patient in the United States in its global, multicenter, randomized clinical trial comparing the transcatheter Medtronic CoreValve system with surgical aortic valve replacement in patients with severe aortic stenosis who are at intermediate risk to undergo open-heart surgery. The SURTAVI (Medtronic CoreValve Surgical Replacement and Transcatheter Aortic Valve Implantation) trial is evaluating the CoreValve System in less-sick patients who are typically treated with open-heart surgical aortic valve replacement. The heart team of Brijeshwar Maini, MD, and Mubashir Mumtaz, MD, performed the first patient procedures in the United States at Pinnacle Health System in Harrisburg, Pennsylvania.

In the company's announcement, the trial's coprincipal investigator Michael Reardon, MD, commented, “The SURTAVI trial will provide guidance on how to best address intermediate risk patients, who, along with their physicians, are looking for less invasive options for treating aortic stenosis. The trial may demonstrate that the CoreValve system is beneficial to this broader population of patients who are looking for alternative treatments.” Dr. Reardon is Weill Cornell Professor of Cardiothoracic Surgery at the Methodist DeBakey Heart and Vascular Center in Houston.

According to Medtronic, the global SURTAVI trial will include approximately 2,500 patients. These patients will be evaluated and treated by experienced heart teams that include interventional cardiologists and cardiac surgeons. The trial will evaluate whether the CoreValve system is noninferior to surgical aortic valve replacement, based on the composite primary endpoint of all-cause mortality and disabling stroke at 24 months.

Patients considered for the trial include those with severe, symptomatic aortic stenosis who are classified as intermediate surgical risk, as defined by the Society of Thoracic Surgeons as a predicted mortality risk of ≥ 4% and ≤ 10%. Patients will be randomized on a 1:1 basis to either CoreValve implantation or surgical aortic valve replacement. The company noted that CoreValve implantation can be performed by transfemoral, subclavian, or direct aortic access, depending on the needs of the patient. All patients will be followed through 5 years.

In July 2012, Medtronic announced the global commencement of the SURTAVI trial. The Chairman of the SURTAVI trial is Patrick Serruys, MD, Professor of Medicine and Head of the Department of Interventional Cardiology at Erasmus Medical Center in Rotterdam, The Netherlands.

The company advised that in the United States, the CoreValve system is currently limited to investigational use. In Europe, the CoreValve system received CE Mark approval in 2007 and is approved for implantation via the direct aortic approach and the subclavian approach. It is available in CE Mark countries in three sizes (26, 29, and 31 mm).