Edwards MITRIS RESILIA Valve Receives CE Mark for Mitral Replacement Surgeries
Edwards Lifesciences today announced it received CE Mark for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart's mitral position. The MITRIS RESILIA valve is made with innovative bovine pericardial tissue technology that reduces calcium build up on the valve. This technology preserves and protects the tissue, allowing the valve to potentially last longer than conventional bioprosthetic valves.*
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231025088486/en/
The MITRIS RESILIA valve is made with innovative tissue technology RESILIA allowing the valve to potentially last longer than conventional bioprosthetic valves.* (Photo: Business Wire)
The MITRIS RESILIA valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. The low-profile valve is based on the Edwards PERIMOUNT valve design with a nitinol wireform, which allows it to fold inward during implantation. The MITRIS RESILIA valve is visible under fluoroscopy, which facilitates potential future transcatheter interventions for patients.
Recent data on the RESILIA tissue from the COMMENCE aortic trial reported encouraging results with low rates of structural valve deterioration (99.3% freedom from structural valve deterioration), clinically stable gradients and freedom from reoperation (97.2%) through seven years. Additionally, the COMMENCE mitral trial demonstrated clinically stable hemodynamics and freedom from structural valve deterioration (98,7%) at 5 years.
The RESILIA anti-calcification technology also allows devices to be stored under dry packaging conditions, facilitating ease of use.
“Mitral valve disease is prevalent and patients experience the disease in various ways. For patients who need mitral valve replacement, the advanced MITRIS RESILIA valve, designed to mimic the native valve, is based on a trusted pericardial PERIMOUNT” says Dr. Daniel Pereda Arnau, Head of Section, Cardiac Surgery Department, H. Clínic de Barcelona. “As valve durability is becoming increasingly important, the integrity-preservation technology incorporated in the RESILIA tissue that will potentially allow the valve to last longer, is critical.”
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.
“Edwards Lifesciences is committed to addressing the needs of patients with structural heart disease,” says John Barry, Edwards' Senior Vice President Surgical Europe. “Our RESILIA tissue technology is designed for enhanced durability, supporting improved quality of life for patients and relieving the burden on healthcare systems.”
The MITRIS RESILIA valve received FDA approval in 2022 in the United States. The introduction of the MITRIS RESILIA valve into the portfolio demonstrates Edwards’ continuous investment in innovation for the benefits and the quality of life of patients.
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 LinkedIn and Twitter.
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, MITRIS, MITRIS RESILIA, PERIMOUNT, 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.
*No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Julie Tracol, +41 (0)75 431 74 95
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Revolutionizing Water Stewardship – The City of Dire Dawa and Nedamco Africa Unveil Cutting-Edge Water Management Platform Initiative at COP28 | December 9th 2023 | COP28UAE Press Center9.12.2023 10:00:00 CET | Press release
Today, at COP28 in the UAE, the city of Dire Dawa (Ethiopia) Water Supply and Sewerage Authority (DDWSSA) and Nedamco Africa together with its partners Microsoft, Deltares, Hulo.ai and Isle Utilities announced the launch of the “Nedamco Catchment-City-Waste Water Management” (CCW) project for the city of Dire Dawa. The CCW solution by Nedamco Africa and its partners Microsoft, Deltares and Hulo.ai is an integrated technology platform that directly addresses the critical challenges of water losses and inefficient management, prevalent in rapidly urbanizing regions like Dire Dawa. It embodies a holistic approach to water management by harnessing digital twin technology, AI/ML, and satellite imagery to deliver comprehensive monitoring of water infrastructures, detect leakages, and make climate impact predictions with the goal to provide more access to water, more water availability as well as improved water quality. With the deployment of the CCW platform Dire Dawa envisions a transformat
Newmont Announces Successful Early Tender Results for the Exchange Offers and Consent Solicitations9.12.2023 01:51:00 CET | Press release
Newmont Corporation (Newmont or the Company) announced today, in connection with the previously announced offers to exchange (each, an “Exchange Offer” and, collectively, the “Exchange Offers”) any and all outstanding notes (the “Existing Newcrest Notes”) issued by Newcrest Finance Pty Limited, a wholly owned subsidiary of Newmont (“Newcrest Finance” and, together with Newmont, the “Issuers”), for (1) up to $1.65 billion aggregate principal amount of new notes to be issued by the Issuers (the “New Newmont Notes”) and (2) cash, and related consent solicitations (each, a “Consent Solicitation” and, collectively, the “Consent Solicitations”) to adopt certain proposed amendments to each of the indentures governing the Existing Newcrest Notes (the “Existing Newcrest Indentures Amendments”), that the Issuers have received tenders with respect to the aggregate principal amounts of Existing Newcrest Notes set forth below, which constitute the requisite consents needed to adopt the Existing New
Board Named a Leader in Gartner® Magic Quadrant™ for Financial Planning Software8.12.2023 17:18:00 CET | Press release
Board, the global leader for Intelligent Planning Solutions, today announced that it has been named a Leader in the 2023 Gartner Magic Quadrant for Financial Planning Software. The evaluation was based on specific criteria that analyzed Board’s overall Completeness of Vision and Ability to Execute. “We are thrilled to be named a Leader for the second consecutive year. We believe this recognition is indicative of the incredible value and positive impact our Intelligent Planning Solutions bring to global businesses,” said Jeff Casale, CEO of Board. “In today’s uncertain markets, organizations need a trusted enterprise partner to help innovate and enhance their financial planning and analysis processes to plan smarter and succeed faster. Our solution integrates planning processes in a single platform, offering strategy, finance, and operations with real-time analysis and data sharing, to deliver a truly intelligent approach.” A Gartner Magic Quadrant is a culmination of research in a spec
HCLTech Expands Footprint in Romania With New Global Delivery Center in Iași8.12.2023 15:56:00 CET | Press release
HCLTech, a leading global technology company, announced the launch of its new Global Delivery Center (GDC) in Iași, Romania. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231208755841/en/ Mayor of Iași, Mihai Chirica, cuts the inaugural ribbon of HCLTech’s new delivery center with the company’s CEO and MD, C Vijayakumar; its Romania country leader, Iulian Paduraru; and SVP, Shiv Walia. (Photo: Business Wire) The new state-of-the art center in Iași will provide next-generation digital, engineering, cloud and AI solutions. The center expands HCLTech’s presence in Romania and underscores its commitment to the country as part of its nearshore strategy to serve global clients. “This is a significant milestone for HCLTech in Romania as we continue our growth journey and serve our global clients with new capabilities in the latest technologies. We remain committed to our people and local communities and will continue investing in
Michelob Ultra Partners With Lionel Messi to Announce Being Named the Official Global Beer Sponsor of CONMEBOL Copa América USA 2024™8.12.2023 15:00:00 CET | Press release
AB InBev (Brussel:ABI) (BMV:ANB) (JSE:ANH) (NYSE:BUD), the world’s leading brewer, and CONMEBOL (Confederación Sudamericana de Fútbol), the governing body of South American football, will elevate their partnership with Michelob Ultra as the Official Global Beer Sponsor of Copa América USA 2024™. This renewed agreement deepens the company’s longstanding commitment to fans around the globe through the world’s most popular sporting events. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231208607579/en/ Michelob Ultra partners with Lionel Messi to announce being named the Official Global Beer Sponsor of CONMEBOL Copa América USA 2024™ (Photo: Business Wire) Michelob Ultra is proud to also announce that CONMEBOL Copa América champion and global football icon, Lionel Messi, will be a new brand ambassador. He shared his excitement for the news: “I am so proud to join Michelob Ultra for its activations at CONMEBOL Copa América USA 2