Edwards Launches SAPIEN 3 With Alterra Prestent in Europe for Transcatheter Pulmonic Valve Implantation
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
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.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
Access Advance Announces HEVC Advance and VVC Advance Pricing through 203022.7.2025 03:00:00 EEST | Press release
Access Advance LLC (“Advance”) today announced the results of several significant decisions by the Licensors in both the HEVC Advance and VVC Advance Patent Pools. Both patent pools opted to maintain their current royalty rates and caps for Licensees who sign before December 31, 2025, and to extend an incentive that aligns the royalty caps for Advance’s Multi-Codec Bridging Agreement (“MCBA”) and the VVC Advance Patent Pool for Licensees who sign the MCBA during the same period. The result is that Licensees who join the HEVC Advance program, gaining access to more than 27,000 patents, on or before December 31, 2025, can lock in current rates and caps through 2030. This protection applies both to ongoing royalty obligations and calculation of royalties due for past sales. Additionally, both current and new HEVC Advance Licensees who join the VVC Advance Patent Pool and execute the MCBA by December 31, 2025, will enjoy MCBA royalty caps that match the royalty caps for the VVC Advance pro
MayMaan Launches Engine Integration Program to Accelerate Clean Combustion Deployment and Market Adoption21.7.2025 20:34:00 EEST | Press release
MayMaan, a scale-up innovator, transforming combustion technology, is announcing a robust and scalable partnership model to support the transition to more efficient power systems across global industries whilst cutting harmful emissions such as NOx and SOx to levels that are practically immeasurable. At the heart of MayMaan’s offering is its proprietary AquaStroke® technology, which runs on a revolutionary 70% water and 30% ethanol fuel blend. This patented system delivers high torque and reliability while dramatically reducing emissions—offering a compelling alternative to diesel engines and electrification overhauls. “Our technology is more than a breakthrough—it’s a platform designed to help others succeed,” said Doron Shmueli, Founder and CEO at MayMaan. “From manufacturers to distributors, we provide a full solution—ready to integrate, easy to scale, and built for the energy demands of tomorrow.” Tailored Solutions for Industry Leaders MayMaan’s clean combustion platform is now av
Armis Named a Leader in Unified Vulnerability Management Solutions, Q3 2025 Evaluation21.7.2025 18:25:00 EEST | Press release
Armis, the cyber exposure management & security company, today announced that it has been named a Leader in The Forrester Wave™: Unified Vulnerability Management Solutions, Q3 2025. In this Forrester Wave™, Armis is ranked a Leader and achieved the highest score in the Current Offering category. According to the report, “Armis’ strategy is grounded in proactive security principles… Armis is an excellent fit for either beginner organizations starting their proactive security journey or mature organizations that need leading vulnerability response capabilities.” “I believe Armis stood out as a Leader because Armis CentrixTM is different – it’s a platform built to help organizations reduce cyber risk, not just report on it,” said Yevgeny Dibrov, CEO and Co-Founder of Armis. “We are redefining what security should look like in a connected world, helping organizations move from passive defense to proactive control so that they can take action before there’s any impact on their environment.
DevvStream Completes $10M Initial Funding to Launch $300M Asset-Backed Digital Infrastructure and Sustainability Strategy21.7.2025 18:00:00 EEST | Press release
DevvStream Corp. (Nasdaq: DEVS) (“DevvStream” or the “Company”), a leading carbon management firm specializing in the development, investment, and sale of environmental assets, today announced that it has entered into a securities purchase agreement for the issuance of up to (US)$300 million in senior secured convertible notes (“Senior Notes”), advancing its strategic initiative to build a blockchain-based treasury and launch a tokenization platform for sustainability-linked infrastructure. The securities purchase agreement provides for the issuance of up to (US)$300 million in Senior Notes with Helena Partners, which issuances will be funded in multiple tranches. An initial funding of (US)$10 million was completed on July 18, 2025. Key Highlights: Under the agreement, DevvStream will allocate 75% of the net proceeds (70% of the initial tranche) toward the purchase of liquid digital assets that offer 24/7 liquidity, serve as non-correlated stores of value, and may be used as collateral
McCauley Propeller Systems High-Performance C780 Propeller Now Factory Standard for New Beechcraft King Air 360 Customers21.7.2025 16:00:00 EEST | Press release
McCauley Propeller Systems, a division of Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced its C780 propeller, which had previously been optional for factory installation, is now standard for all new commercial customers of the Beechcraft King Air 360. The first King Air 360 equipped with the propeller recently rolled out of production at Textron Aviation’s factory in Wichita, Kansas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250720080635/en/ McCauley Propeller Systems high-performance C780 propeller now factory standard for new Beechcraft King Air 360 customers (Photo Credit: McCauley Propeller Systems) "As a leading full-line propeller manufacturer, being featured on the factory line of the legendary Beechcraft King Air 360 underscores our commitment to excellence," said Jason Hull, vice president and general manager, McCauley Propeller Systems. “The C780 offers a sophisticated and durable de
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