Business Wire

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.

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Rowan Unsworth, +41 (0)79 564 20 82, rowan_unsworth@edwards.com

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