Edwards Treats First Patient In U.S. Clinical Trial Evaluating Minimally Invasive Device For Mitral Valve Disease
Monday, December 21, 2020
IRVINE, Calif., Dec. 21, 2020 -- Edwards Lifesciences (NYSE: EW), today announced that the first patient has been treated in the RESTORE clinical trial, which will evaluate the safety and effectiveness of the investigational HARPOON Beating Heart Mitral Valve Repair System in the United States and Canada. The HARPOON system uses a less-invasive technique than open-heart surgery in order to treat a type of heart disease called severe degenerative mitral valve regurgitation, which occurs when there is damage to the mitral valve that prevents proper functioning of the valve. The procedure took place at the University of Maryland Medical Center in Baltimore.
"Symptomatic patients with severe degenerative mitral valve regurgitation can experience limitations in their day-to-day life ranging from reduced physical activity to more serious complications," said Vinod Thourani, M.D., national principal investigator of the RESTORE trial and Marcus Chief of Cardiovascular Surgery for Piedmont Healthcare, the Marcus Heart and Vascular Center and Marcus Heart Valve Center. "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."
The HARPOON system, which was developed by researchers at the University of Maryland Heart and Vascular Center, requires only a small incision to repair the mitral valve. The procedure is conducted while the heart is still beating, eliminating the need for a heart bypass machine to do the work of the heart and lungs while the heart is stopped for surgery.
Read the press release from Edwards Lifesciences.