Edwards' KONECT RESILIA Aortic Valved Conduit Receives FDA Approval For Complex Aortic Valve Surgeries

Rhea-AI Summary

Edwards Lifesciences (NYSE: EW) announced FDA approval for the KONECT RESILIA aortic valved conduit, the first ready-to-implant solution for bio-Bentall procedures. This innovative device utilizes RESILIA tissue technology, enhancing valve durability and simplifying surgical procedures. The KONECT device aims to streamline emergency surgeries, as up to 30% of Bentall procedures occur in urgent situations. Edwards continues to lead in patient-focused innovations for structural heart disease and is committed to improving patient outcomes through advanced technologies.

Positive

• FDA approval of the KONECT RESILIA aortic valved conduit enhances market offering.
• Innovative RESILIA tissue technology improves valve durability and simplifies surgery.
• Addresses a significant need with up to 30% of Bentall procedures performed in emergencies.

Negative

• Regulatory and clinical uncertainties may affect adoption and market performance.

IRVINE, Calif., July 15, 2020 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today 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.

"The KONECT device combines Edwards' expertise innovating bovine pericardial tissue technologies, such as RESILIA, with the proven clinical history of the Gelweave Valsalva graft," said Daveen Chopra, Edwards' corporate vice president, surgical structural heart. "Because the typical patient is under the age of 60, advanced technologies such as the KONECT device with the RESILIA tissue might provide extended valve durability for a more active patient population."

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.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected outcomes after more expanded clinical experience, unexpected changes or delays related to product supply, potentials for unexpected regulatory or quality developments, competitive dynamics, or unexpected delays or changes in patient access, litigation or clinician acceptance. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2019, and the Quarterly Report on Form 10-Q for the quarter ended March 31, 2020.

Edwards, Edwards Lifesciences, the stylized E logo, KONECT, KONECT RESILIA, Physio, Physio Flex and RESILIA are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries.

 

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SOURCE Edwards Lifesciences Corporation

FAQ

What is the KONECT RESILIA aortic valved conduit approved by the FDA?

The KONECT RESILIA aortic valved conduit is a ready-to-implant device for bio-Bentall procedures, enhancing surgical efficiency and patient outcomes.

What are the benefits of the KONECT device for Bentall procedures?

The KONECT device offers improved valve durability and simplifies the surgical process, addressing critical needs in emergency settings.

How does the KONECT device impact patient care?

It streamlines complex surgeries, potentially improving outcomes for patients with aortic valve and root diseases.

When was the KONECT RESILIA conduit approved by the FDA?

The KONECT RESILIA aortic valved conduit received FDA approval on July 15, 2020.

What is the market potential for the KONECT device?

Given its innovative features and the frequency of Bentall procedures, the KONECT device has significant market potential.