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

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

LUMI AI Factory Selects IQM to Deploy Advanced Quantum Computer, Accelerating Hybrid HPC and AI Development8.7.2026 14:00:00 CEST | Press release

The Halocene H4 quantum computer, named LUMI-IQ, will be delivered and installed in 2027 The system will be hosted at CSC – IT Center for Science in Finland and integrated into the LUMI AI Factory The system will provide researchers, industry innovators, and developers across Europe with a unique, advanced experimental platform where quantum computing and artificial intelligence converge The LUMI AI Factory, led by CSC – IT Center for Science, has selected IQM Quantum Computers (Nasdaq: IQMX) to deliver IQM Halocene H4, an advanced quantum computer aimed at accelerating hybrid high-performance computing, artificial intelligence, and quantum computing capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708006791/en/ LUMI AI Factory selects IQM to deploy advanced quantum computer, accelerating hybrid HPC and AI development IQM Halocene H4 is the first and most advanced on-premises superconducting quantum computer o

Merck Announces FDA Breakthrough Therapy Designation for Enpatoran in Lupus Patients With Active Skin Manifestations8.7.2026 14:00:00 CEST | Press release

Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapiesFDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestationsEnpatoran's potential to go beyond current treatment standards in lupus prompted FDA´s breakthrough designation, which is designed to expedite drug development and reviewNot intended for Canada-, UK- or US-based media Merck, a leading science and technology company, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to enpatoran for the treatment of lupus with active cutaneous manifestations. Enpatoran is an oral selective toll-like receptor (TLR) 7/8 inhibitor, designed to modulate pathways central to lupus-related inflammation. “For the 85% of lupus patients whose disease includes skin manif

Fastly Joins DIMPACT to Collaborate on Digital Sustainability8.7.2026 14:00:00 CEST | Press release

Fastly Brings Leading Cloud Edge Expertise to Help DIMPACT Members Understand and Optimize Digital Carbon Footprints Fastly, Inc. (NASDAQ: FSLY), a leading global edge cloud platform, today announced it has become a participant of DIMPACT, the coalition of leading organizations working to align industry changemakers and policymakers around meaningful, science-based solutions that reduce the environmental impacts of serving digital media products. As the first edge cloud platform provider to join the coalition, Fastly brings critical, real-world edge network data and infrastructure expertise and a transparent approach to emissions calculation and reporting to help major media, streaming, and publishing companies understand and optimize their digital carbon footprints. “We’re thrilled to welcome Fastly to the DIMPACT initiative. Their participation strengthens DIMPACT's ability to advance a more accurate, data-driven approach to measuring and reducing digital emissions,” said Jason Bell,

PubNub Introduces Blocks.ai: The Control Plane and Network Layer For AI Agents8.7.2026 14:00:00 CEST | Press release

Connect and control agents from everywhere, across any network and device, on the Blocks Network. PubNub introduces Blocks.ai today, a global network to connect and control agents across all agent frameworks, providers, and APIs. Blocks.ai lets developers reach their existing AI agents regardless of where they are hosted. Blocks Network supports all AI agent use cases without opening inbound ports, setting up tunnels, changing DNS, or modifying firewall rules. For more than a decade, PubNub has been the infrastructure and platform for real-time connectivity supporting billions of devices, now, PubNub delivers Blocks Network connecting the Internet of Agents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708521206/en/ AI agents have become increasingly critical to businesses who want control over their models, code, and data. But once those agents are running locally or behind a firewall, making them reachable from custom

STEMCELL Technologies and CCRM Partner to Expand Access to Matched GMP and RUO iPSC Lines for Cell Therapy Development8.7.2026 14:00:00 CEST | Press release

Partnership pairs GMP-manufactured iPSC lines with matched RUO equivalents, giving developers well-characterized, donor-eligible starting materials from early research through clinical development. Supporting comparability data for the RUO and GMP lines to be presented at the 2026 ISSCR Annual Meeting in Montréal, Canada. STEMCELL Technologies and the Centre for Commercialization of Regenerative Medicine (CCRM) today announced a partnership to expand access to high-quality human induced pluripotent stem cell (iPSC) starting materials, giving cell therapy developers worldwide a faster, lower-risk path from research to the clinic. Under the agreement, STEMCELL will manufacture and distribute research-use-only (RUO) iPSC lines derived directly from LineaBio's Good Manufacturing Practices (GMP) iPSC lines, and will offer the matched GMP lines to developers worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708212795/en

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