Enrollment Begins in RESTORE Trial of Edwards’ Harpoon System for Mitral Valve Repair

December 21, 2020—Edwards Lifesciences announced that the first patient has been treated in the RESTORE clinical trial, which is evaluating the safety and effectiveness of the company’s investigational Harpoon beating heart mitral valve repair system in the United States and Canada.

The procedure was performed at the University of Maryland Medical Center in Baltimore, Maryland. The procedure requires a small incision and is conducted while the heart is still beating, eliminating the need for a heart bypass machine. The Harpoon device, which was developed at the University of Maryland Heart and Vascular Center, is limited by United State law to investigational use only, advised the company.

According to the company, the RESTORE clinical trial is an investigational device exempt study that will enroll and follow up to 360 patients who need mitral valve repair because of severe degenerative mitral regurgitation (MR).

Vinod Thourani, MD, serves as the national Principal Investigator of the RESTORE trial. Dr. Thourani is Marcus Chief of Cardiovascular Surgery for Piedmont Healthcare, the Marcus Heart and Vascular Center and Marcus Heart Valve Center in Atlanta, Georgia.

In Edwards’ press release, Dr. Thourani commented, “Symptomatic patients with severe degenerative MR can experience limitations in their day-to-day life ranging from reduced physical activity to more serious complications. Utilizing less invasive approaches, we can potentially reduce the need for traditional open heart surgery and the hardships associated with a patient’s healing and recovery process.”

More information about RESTORE, including a list of sites in the United States currently enrolling patients, is available at the trial’s website for patients, www.theRESTOREtrial.com.