Edwards Treats First Patient In U.S. Clinical Trial Evaluating Minimally Invasive Device For Mitral Valve Disease
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.
"The HARPOON Beating Heart Mitral Valve Repair System is a testament to Edwards' commitment to the research and development of innovative, patient-focused technologies that have the potential to transform cardiac surgery," said Daveen Chopra, Edwards' corporate vice president, surgical structural heart. "The RESTORE clinical trial will add to the growing body of evidence for the HARPOON system, which is also being evaluated as part of the ASCEND post-market study in Europe."
The RESTORE clinical trial is an investigational device exempt study that will enroll and follow up to 360 patients who need mitral valve repair surgery due to severe degenerative mitral valve regurgitation. Degenerative mitral valve regurgitation is commonly caused by mitral valve prolapse, which prevents the valve from closing properly and causes blood to leak backwards as the heart contracts. The condition is associated with cardiovascular issues such as chest pain, shortness of breath and fatigue. In the most serious cases, it can lead to heart failure.
Patients interested in participating in the RESTORE trial can visit www.theRESTOREtrial.com for more information, as well as a list of sites in the U.S. that are currently enrolling patients.
Caution: Investigational device. Limited by Federal (United States) law to investigational use. The device is not available for marketing or commercial sale in the United States. Edwards Lifesciences is the sponsor of the RESTORE trial (IDE G200067).
Dr. Thourani is a consultant to Edwards Lifesciences.
About Edwards Lifesciences
Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to statements made by Dr. Thourani and Mr. Chopra and statements regarding expected product benefits, patient outcomes, future plans related to the product lines, objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.
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