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

Men’s Interest in Appearance Is Growing: 36% Say Looking Their Best Matters More Than Five Years Ago, NIQ Finds30.10.2026 11:45:00 CET | Press release

New NIQ insights reveal changing attitudes toward appearance and aging, while purchasing data points to opportunities beyond products marketed specifically to men NielsenIQ (NYSE: NIQ), a global leader in consumer intelligence, today shared findings showing that 36% of men say looking their best, including beauty and skincare, matters more to them than it did five years ago. More than half (54%) say aging well has become more important over the same period. Yet the opportunity for beauty brands may extend beyond products specifically marketed to men. Across 10 Western European markets, sales value of skincare positioned for all genders grew 7% year over year, while male-targeted skincare was flat. The findings suggest that brands should look beyond traditional product positioning to understand men’s needs, shopping behavior, and the products they choose. In its report, The Permission Gap: The Global State of Male Beauty, NIQ examines how social expectations, generational differences an

INSEAD Establishes Thrive Lab With US$3 Million Funding From Google.org and Google DeepMind30.10.2026 10:00:00 CET | Press release

Launched at INSEAD AI Forum Asia, the new Lab is set to advance global academic research on the impact of AI on human connectivity, meaning and wellbeing in work and life INSEAD, The Business School for the World, today announced it has received US$3 million in funding from Google.org and Google DeepMind. The funding will support the Research Lab for Human and Organisational Thriving (INSEAD Thrive Lab), aimed at accelerating global research on how people and organisations can flourish in an era of continuous technological transformation. Artificial intelligence is emerging as the most consequential technology that profoundly shapes how people learn, work, live and interact with one another. While it presents near limitless possibilities, we need to give careful attention to the potential risks. How can we strengthen our human, social and psychological capital amid relentless technological change? And how must our ecosystems of learning – spanning educational, community, and profession

Sharjah Unveils Uruk: A New Generation of Sustainable Cities Built for the Post-AI Era29.10.2026 19:15:00 CET | Press release

In the presence of His Highness Sheikh Dr. Sultan bin Mohammed Al Qasimi, Supreme Council Member and Ruler of Sharjah, and Her Highness Sheikha Bodour bint Sultan Al Qasimi, President of American University of Sharjah and Chairperson of Sharjah Research, Technology and Innovation Park, a pioneering model for a new generation of cities designed for the post-AI era called “Uruk.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261029129346/en/ H.H. Sheikh Dr. Sultan bin Mohammed Al Qasimi, Ruler of Sharjah, during the inauguration of “Uruk” (Photo: AETOSWire) The project was revealed at the opening of the second edition of Sharjah Next, through a strategic partnership between Sharjah Research, Technology and Innovation Park (SPARK), American University of Sharjah (AUS) and SEE Holding, bringing together their capabilities in innovation, scientific research and sustainable urban development. Uruk introduces a new vision for urba

Motive and Vivo Brazil Win 2026 Leading Lights Award for Network API Monetization29.10.2026 17:35:00 CET | Press release

Award recognizes live GSMA Open Gateway deployment replacing SMS OTP with SIM-based silent authentication Motive, a global leader in entitlement, connected device and service management and Vivo Brazil, Brazil’s largest operator and part of the Telefónica Group, have won the 2026 Light Reading Leading Lights Award for Outstanding Use Case: Network API Monetization for the first commercial scale deployment of SIM-based silent authentication in Latin America. SMS OTP remains relevant as an authentication method due to its broad reach, working on virtually any type of mobile device. SIM-based silent authentication takes this experience a step further by eliminating the need to receive and manually enter codes. The result is a simpler, more seamless user journey that reduces friction and can help lower abandonment rates while increasing customer conversion and retention. Using Motive’s CAMARA-compliant Entitlement Server, Vivo can now verify a subscriber’s phone number directly without req

REV Ocean Appoints Paul Baribault as CEO Ahead of 2027 Global Operations29.10.2026 15:45:00 CET | Press release

Global conservation and philanthropic leader to spearhead REV Ocean's next chapter, connecting world-class science with international collaboration and ocean protection REV Ocean has appointed Paul Baribault as Chief Executive Officer as the organization moves towards the international debut of its 195-metre research vessel in Rio de Janeiro in April 2027, alongside the UN Ocean Decade Conference. One of the world's largest privately owned research and exploration vessels, REV represents a major philanthropic investment in ocean science. With nine laboratories, advanced deep-sea exploration vehicles and dedicated collaboration facilities, it is designed to give scientists access to world-class research infrastructure and connect their discoveries with the people and institutions able to drive ocean protection. Baribault joins as REV Ocean moves from a decade of engineering and construction into international operations. His mandate will be to build the international partnerships, fundi

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