EDWARDS’ KONECT RESILIA AORTIC VALVED CONDUIT RECEIVES CE MARK FOR COMPLEX AORTIC VALVE SURGERIES

Edwards’ KONECT RESILIA Aortic Valved Conduit Receives CE Mark FOR COMPLEX AORTIC VALVE SURGERIES

NEWBURY, July 25 2025 – Edwards Lifesciences today announced that it has received CE Mark for its KONECT RESILIA aortic valved conduit (AVC), the first ready-to-implant solution with RESILIA technology specifically designed for bio-Bentall procedures. This complex surgery involves the replacement of the aortic valve, aortic root and ascending aorta.

With more than 65 years of expertise built on innovation and partnership with physicians, Edwards has consistently pioneered first-of-their-kind therapies that have transformed the treatment of structural heart disease (SHD). As the latest addition in Edwards’ class of resilient bovine pericardial valves, the ready-to-implant* KONECT RESILIA aortic valved conduit supports patients in maintaining active lifestyles and simplifies bio-Bentall procedures by eliminating procedural steps**.

The KONECT RESILIA device features advanced RESILIA tissue, which incorporates integrity-preservation technology and is designed to offer the potential for extended durability. This proprietary tissue technology also enables dry packaging, facilitating ease of use during the procedure.

“As the only global MedTech company exclusively focused on structural heart disease, Edwards has a long history of pioneering breakthrough implantable devices to address the unmet needs of patients facing life-threatening and chronically debilitating conditions,” said Annette Brüls, Corporate Vice President, EMEA, Canada, and Latin America at Edwards Lifesciences. “The KONECT device is the latest addition to our growing portfolio in the region and reflects our commitment to pioneering therapies that transform structural heart disease care and create lasting value for patients, physicians and healthcare systems.”

Bentall procedures are performed when patients with aortic valve disease experience a combination of serious and sometimes life-threatening conditions such as aortic aneurysms, dissections or connective tissue disorders.

Approximately 20% of Bentall procedures are performed in an emergency setting¹. The pre-assembled KONECT RESILIA aortic valved conduit intuitively eliminates procedural steps** which is especially important in emergency cases with the potential to positively impact patient outcomes.

“Until now, surgeons using bovine tissue valves for Bentall procedures had to assemble the valve and conduit themselves during surgery, as no pre-assembled biological option was approved in Europe,” said Professor Ruggero de Paulis, Director, Department of Cardiac Surgery, European Hospital Rome (Italy) and early contributor to the development of the KONECT device. “The KONECT RESILIA device transforms the treatment of the disease by offering a ready-to-use solution bringing together two advanced technologies - RESILIA tissue technology on the aortic valve combined with the proven clinical history of the Gelweave Valsalva graft. A major step forward that can help simplify a technically demanding procedure and improve surgical efficiencies for better patient outcomes.”

About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn.

# # #

Edwards, Edwards Lifesciences and the stylized E logo, KONECT, KONECT RESILIA, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

* Consult instructions for use for device preparation instructions

**As compared to self-assembled tissue valved conduits

1. Based on US data: Calderon-Rojas, R., Bagameri, G., Schaff, H. V., Crestanello, J. A., Arghami, A., Rowse, P., Yee, C., Saran, N., Spencer, P. J., Dearani, J. A., & Shrestha, M. (2025). Early experience with a prefabricated bioprosthetic aortic valved conduit: The first hundred. ScienceDirect.