Edwards Launches SAPIEN 3 With Alterra Prestent in Europe for Transcatheter Pulmonic Valve Implantation
17.9.2024 01:01:00 CEST | Business Wire | Press release
Edwards Lifesciences today announced the launch in Europe of the SAPIEN 3 transcatheter pulmonary valve implantation (TPVI) system with Alterra adaptive prestent, expanding minimally invasive treatment options to a broader range of patients with congenital heart conditions.
Edwards’ SAPIEN 3 TPV system with Alterra adaptive prestent (SAPIEN 3 with Alterra) recently received CE mark1 for use in the management of patients with severe pulmonary regurgitation. This new system has been designed to address a wider range of anatomies, bringing the excellent clinical outcomes and performance of the SAPIEN 3 transcatheter pulmonary valve2 to more patients and broadening treatment options over the lifetime of patients.
“Patients with congenital heart conditions often undergo multiple invasive surgical procedures, significantly impacting their quality of life,” said Professor Damien Kenny, consultant congenital cardiologist at Crumlin Hospital and the Mater Hospital, Dublin, Ireland. “The addition of the innovative Alterra adaptive prestent to the SAPIEN 3 pulmonic platform means that we can now offer minimally invasive therapy to a wider range of pulmonic patients, and delay their potential need for future open-heart surgeries.”
The proven SAPIEN 3 transcatheter valve is combined with the Alterra adaptive prestent, building on generations of valve technology and innovation. The innovative Alterra prestent addresses variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the SAPIEN 3 valve3. The specifically designed Alterra delivery system offers smooth tracking to the pulmonary artery, and the unique ability to recapture and reposition if needed.
“Patients requiring pulmonic heart valve replacement are a diverse group with complex challenges, including adolescents and adults with Tetralogy of Fallot or other congenital heart valve defects,” said Gregory Servotte, senior vice president of transcatheter heart valves EU at Edwards. “I am proud of the advancement of the SAPIEN 3 with Alterra and in the dedication of our team here at Edwards focused on developing lifesaving innovations to address the significant needs of patients with structural heart disease.”
Notes to Editors
1. The 29mm Edwards SAPIEN 3 TPV system with Alterra adaptive prestent is indicated for use in the management of patients with severe pulmonary regurgitation who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement.
2. Lim DS, et al. Congenital Pulmonic Valve Dysfunction Treated with SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial). Am J Cardiol 2023 Mar 1;190:102−109.
3. Shahanavaz S, et al. Alterra Adaptive Prestent and SAPIEN 3 THV for Congenital Pulmonic Valve Dysfunction: An Early Feasibility Study. JACC Cardiovasc Interv. 2020 Nov 9;13(21):2510-2524
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 and X.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Alterra, SAPIEN and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240916488217/en/
Contacts
Rowan Unsworth, +41 (0)79 564 20 82, rowan_unsworth@edwards.com
Rowan Unsworth, +41 (0)79 564 20 82, rowan_unsworth@edwards.com
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
Philips and Imricor Launch Cardiac Interventional MR Lab Solution, Expanding Longstanding Collaboration27.8.2026 21:27:00 CEST | Press release
Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Imricor Medical Systems (ASX: IMR), a pioneer and world-leading developer of MR-compatible products for interventional MR procedures, today announced a new Interventional MR (iMR) lab solution for Philips 1.5T MR. The first commercially available configuration* combines Philips’ 1.5T MRI platform and Imricor's portfolio of iMR systems and consumables, enabling an MR-guided workflow for cardiac intervention, without compromising on MR field strength. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827693715/en/ Meeting the need for greater tissue insight during cardiac intervention Cardiac arrhythmias affect millions of people worldwide, and catheter ablation is an established and increasingly utilized treatment for many complex cardiac arrhythmias. Yet today, these procedures continue to rely primarily on X-ray fluoroscopy, which provides only
Xsolla Launches Game Biz Institute, an Editorial Platform Where Industry Practitioners Explain the Business of Games27.8.2026 17:32:00 CEST | Press release
New Platform Pairs Independent Researchers and Industry Veterans with Xsolla Experts to Unpack Direct-to-Player Commerce, Monetization, Payments, and Player Retention Xsolla, a global commerce company, today announced the launch of Game Biz Institute (GBI), an editorial platform where named industry practitioners and researchers examine the commercial layer of games: direct-to-player distribution, payments, monetization, user acquisition, and retention. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827362663/en/ Graphic: Xsolla Game design has a curriculum. The business of games does not. Engines, pipelines, production, and narrative are taught at hundreds of universities, while the commercial machinery that determines whether good work becomes a durable company is still learned through expensive trial and error, usually after the decisions that mattered have already been made. GBI was built to close that gap by publishi
Star Wars Zero Company™ Now Available On PC, PlayStation 5 and XBOX Series Consoles27.8.2026 17:00:00 CEST | Press release
Bit Reactor’s Debut Title Combines Tactical Depth and Cinematic Elegance for a New Star Wars StoryWatch the Final Trailer to Witness What’s at Stake in the Galaxy Electronic Arts Inc. and Bit Reactor, in collaboration with Lucasfilm Games, announced today that Star Wars Zero Company™, a single-player turn-based tactics game set in the twilight of the Clone Wars™, is now available for PC via the EA app, Steam, and Epic Games Store, and PlayStation®5 and XBOX Series consoles. In Star Wars Zero Company, former Republic officer Hawks and Zero Company, an elite squad of unconventional professionals for hire, are recruited for an operation by Republic Intelligence. From ex-nobles to ex-cons, they now share one mission: Stop the Infinite Coil, a Separatist-aligned cult, and their leader Kundri Fathom before the deadly Shadow Plague consumes the galaxy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827012810/en/ https://www.yout
Rehlko Joins Wisconsin Data Center Coalition as Newest Energy Resilience Member, Reinforcing Its Role at the Center of AI and Digital Infrastructure Growth27.8.2026 15:15:00 CEST | Press release
Global Energy Resilience Leader Reinforces Its Role at the Center of AI and Digital Infrastructure Growth Through Mission-Critical Power Expertise Rehlko, a global industrial energy resilience platform providing custom-engineered, integrated power solutions for mission-critical infrastructure worldwide, today announced it has joined the Wisconsin Data Center Coalition (WIDCC) as the organization's newest energy resilience member. The membership reflects Rehlko's commitment to advancing Wisconsin's role as a leader in responsible AI infrastructure development, built on reliable and scalable power. Rapid growth in hyperscale and enterprise data center investment is reshaping markets across the world, and Rehlko is building the power infrastructure that makes it possible. Sitting at the intersection of the structural forces driving AI infrastructure expansion, grid reliability, and accelerating electrification, Rehlko brings more than a century of engineering depth and lifecycle capabilit
GenNx360 Capital Partners Closes Fourth Flagship Fund at $865 Million27.8.2026 14:30:00 CEST | Press release
Fund IV success is the result of two decades of proven performance backing lower middle market industrial services and business services companies GenNx360 Capital Partners (“GenNx360” or “the Firm”), a New York City-based private equity firm investing in U.S. lower middle market industrial services and business services companies, today announced the successful closing of GenNx360 Capital Partners IV, L.P. (“Fund IV” or “the Fund”), with $865 million in commitments, exceeding its target. Fund IV is the largest fund raised in GenNx360’s history. Fund IV was supported by a diverse group of existing and new investors including leading pensions, asset managers, insurance companies, foundations, and family offices, reflecting conviction in the firm’s disciplined investment approach, operational value creation model, and tenured, diverse team. Fund IV will continue GenNx360’s differentiated strategy of partnering with lower middle market founders and management teams to scale essential serv
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom