Sustainability report

Product safety & quality

Edwards Lifesciences’ work to maintain product safety and quality supports our aspiration of excelling as a trusted partner through distinguished quality and integrity. Creating safe, quality products is the foundation of both our business success and culture. Our reputation rests on delivering innovative, trustworthy products that save patient lives.

Definition

Monitoring, managing and reducing negative health and safety impacts of Edwards’ products. Maintenance of product quality and ensuring Edwards' products are free from any deficiencies or defects.

Our aspirations

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Excelling as a trusted partner through distinguished quality and integrity

Material topics
Highlight story

Edwards PASCAL Transcatheter System Receives Approval for Use in Europe

In 2019, our PASCAL transcatheter valve repair system received CE Mark for the treatment of patients in Europe with mitral regurgitation. Mitral valve disease is complex, varied and prevalent, and patients are in significant need of multiple safe and effective therapies to treat debilitating symptoms that can lead to a high rate of mortality. The introduction of the PASCAL system to clinicians and patients in Europe provides a differentiated, minimally-invasive therapy to address the needs of patients with mitral regurgitation.

In early 2020, the PASCAL system also received European approval for the treatment of European patients with tricuspid regurgitation. "Although the prevalence of tricuspid valve disease and the associated mortality are high, there are limited effective treatment options for these very symptomatic patients, who often cannot have surgery due to the prohibitive risk," said Prof. Jörg Hausleiter, MD, Medizinische Klinik der Ludwig-Maximilians-Universität München in Munich, Germany. "Transcatheter tricuspid therapy can be challenging due to the fragile leaflets and the large defects during valve closure. In our experience, the PASCAL system's independent grasping ability as well as the flexible and less traumatic clasp design are important features for our patients."

The PASCAL system is one of multiple transcatheter repair or replacement therapies designed to address mitral and tricuspid valve diseases that are under development by Edwards. It represents the culmination of 20 years of innovation by Edwards to develop a novel, differentiated and advanced platform for patients in need. The company is building upon a long history of knowledge, experience and commitment to advance transformative therapies and develop a robust body of clinical evidence

Note: The PASCAL repair system is not approved in the United States.