Edwards Lifesciences Corporation issued the following announcement on July 15.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced it received approval from the U.S. Food and Drug Administration (FDA) for the KONECT RESILIA aortic valved conduit (AVC), the first ready-to-implant solution for bio-Bentall procedures, a complex surgery that involves replacement of a patient's aortic valve, aortic root and the ascending aorta.
The KONECT device is the company's latest innovation offering the advanced RESILIA tissue, which incorporates integrity-preservation technology that may help improve valve durability. The RESILIA tissue technology also allows devices to be stored under dry packaging conditions, facilitating ease of use during patient care.
"Until now, surgeons did not have a pre-assembled option that was FDA approved, so those utilizing bovine tissue valves for Bentall procedures needed to manually assemble a valve with a conduit in the operating room," said Joseph E. Bavaria, MD, Brooke Roberts-William M. Measey professor of surgery and vice chief of the division of cardiovascular surgery, University of Pennsylvania. "The KONECT device represents a meaningful advancement that offers surgeons a preassembled device with two leading technologies, which can streamline treatment for patients requiring this complex and technical procedure."
Up to 30% of Bentall procedures are performed in an emergency setting. These procedures are performed when patients with valve disease experience a combination of issues with the aorta, including:
- Aneurysm, a bulging in the aorta that can be life-threatening if it ruptures. Bicuspid aortic valve disease is the leading cause of aortic aneurysms.
- Regurgitation, the leakage of blood backwards into the heart due to the leaflets of the valve not closing properly.
- Separation or tears in the walls of the aorta.
- Marfan's syndrome, a birth defect in connective tissue that weakens the aortic wall.
Edwards is dedicated to partnering with clinicians to develop patient-centric innovations for complex surgical structural heart procedures that improve long-term care and outcomes for patients. For patients with mitral valve disease in which there is no standard solution for treatment, the recently launched Physio Flex annuloplasty ring is the first-ever product of its kind that mimics the natural anatomy of the mitral valve. Edwards is also investing in innovations in the field of beating heart mitral valve therapies, more durable surgical mitral tissue valve replacement, minimally invasive surgical suture securing systems and other surgical structural heart devices.
Dr. Bavaria is a consultant to Edwards Lifesciences.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader of patient-focused medical 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 by Dr. Bavaria 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.
Original source can be found here.
