Edwards’ EVOQUE Valve Greenlit by FDA for Transcatheter Therapy

(Photo By: Edwards Lifesciences)

In a groundbreaking move, Edwards Lifesciences Corporation has achieved a monumental milestone in transcatheter therapy. Their EVOQUE tricuspid valve replacement system has become the first of its kind to earn approval from the U.S. Food and Drug Administration (FDA) for the treatment of tricuspid regurgitation (TR). This announcement marks a significant advancement in the field of structural heart disease management.

What Unmet Needs Does the EVOQUE System Treat?

Tricuspid regurgitation (TR), a condition characterized by the backflow of blood through the tricuspid valve of the heart, has long posed a challenge for clinicians and patients alike. Despite optimal medical therapy (OMT), individuals suffering from symptomatic severe TR often face limited treatment options. Now, with the FDA’s approval of the EVOQUE system, there is newfound hope for these patients.

Everything You Should Know About the EVOQUE System

The EVOQUE system is designed to address the unmet needs of individuals with severe TR. Comprising a nitinol self-expanding frame, an intra-annular sealing skirt, and tissue leaflets crafted from Edwards’ trusted bovine pericardial tissue, this innovative solution offers a promising alternative for those who require tricuspid valve replacement. What sets the EVOQUE system apart is its ability to deliver significant improvements in health status and quality of life for patients who have previously experienced debilitating symptoms.

Edwards Lifesciences: Always an Innovator

In August 2019, the FDA approved a range of transcatheter heart valve devices, including the Sapien 3®, Sapien 3 Ultra®, CoreValve™ Evolut R, and CoreValve™ Evolut PRO valves, for the treatment of low-risk patients. This milestone marked a pivotal moment in cardiovascular care, significantly broadening the scope of patients who can benefit from minimally invasive interventions. By expanding treatment options and enhancing patient outcomes, these approvals have paved the way for a transformative shift in cardiac care.

However, the EVOQUE system’s journey to FDA approval is a testament to Edwards Lifesciences’ commitment to patient-centric innovation. By collaborating closely with clinicians and stakeholders worldwide, the company has ushered in a new era of care for individuals with structural heart disease. The EVOQUE system’s prior CE Mark approval in 2023 solidified its status as the world’s first transcatheter valve replacement therapy for TR, further highlighting the global impact of this breakthrough technology.

The Future of Trancatheter Heart Valve Replacement 

As patient preferences continue to evolve, there is a clear trend towards percutaneous procedures over traditional surgical interventions. This shift is expected to drive substantial growth in transcatheter aortic valve replacement (TAVR) procedural volume and unit sales. With patients increasingly opting for less invasive treatment modalities, the market value for transcatheter heart valve devices is poised for upward trajectory over the forecast period.

Looking ahead, Edwards Lifesciences remains dedicated to advancing patient care and driving meaningful progress in cardiovascular medicine. As they continue to explore the full potential of the EVOQUE system and other transformative therapies, patients can rest assured that they are at the forefront of innovation in heart health.

In conclusion, the FDA approval of Edwards’ EVOQUE tricuspid valve replacement system marks a pivotal moment in the treatment of tricuspid regurgitation. With its proven efficacy, innovative design, and potential to significantly enhance patients’ lives, the EVOQUE system represents an exciting advancement for individuals grappling with this challenging condition. 

To learn more about the US transcatheter heart valve replacement market, we have updated insights as of 2023 with a 10-year market forecast into 2029. Click the button below to receive a complimentary summary of our US Cardiac Surgery market report, which contains a complete chapter on transcatheter heart valve replacement.

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1. https://ir.edwards.com/news/news-details/2024/Edwards-EVOQUE-Valve-Replacement-System-First-Transcatheter-Therapy-to-Earn-FDA-Approval-for-Tricuspid-Valve/default.aspx

2. https://idataresearch.com/product/cardiac-surgery-market-united-states/

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