CoreValve®: High Risk Patient Study Enrollment Complete, FDA Says Yes To Start Intermediate Risk Patient Study

In short

Medtronic, Inc. is announcing twin milestones for its CoreValve® clinical program on the long road to U.S. approval. First, it completed enrollment in its study of high risk patients in its 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.

In addition, FDA has issued conditional approval for Medtronic 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.

Background

The race to dominate the U.S TAVI space is well and truly on. Edwards’ Sapien Valve is probably still in the lead with its existing approval for use in high risk patients. However Medtronic’s Corevalve is hot on Sapien’s heels, especially with the news that FDA has now sanctioned its use in a study relating to what will be a much wider application encompassing patients at intermediate risk for conventional valve surgery. Both devices were CE marked in 2007 and have seen successful adoption in Europe and other non-US markets, Medtronic claiming implant numbers of more than 30,000 in over 60 countries worldwide.

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 U.S. 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 new trial, slightly unimaginatively tagged SURTAVI, will be the largest global, randomised, 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 factors 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.

Clinician comments

“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.”

Regulatory status

The Medtronic CoreValve System is available in the United States for investigational use only.

Source: Medtronic, Inc.