- In February 2024, Edwards Lifesciences Corporation introduced the EVOQUE tricuspid valve replacement system as the first transcatheter therapy approved by the U.S. Food and Drug Administration (FDA) for treating tricuspid regurgitation (TR). The system is indicated to improve health status in patients with severe symptomatic TR despite optimal medical therapy (OMT), when replacement of the tricuspid valve is considered appropriate by a heart team
- In March 2023, Abbott announced FDA approval for its Epic Max stented tissue valve to address aortic regurgitation or stenosis. The Epic Max features an optimized design aimed at enhancing blood flow through the valve, further solidifying its efficacy in treating patients with aortic valve disorders Prosthetic Heart Valve Market Scope
- In March 2022, Edwards Lifesciences received regulatory approval from the U.S. Food and Drug Administration for its MITRIS RESILIA valve. This newly approved device is a bioprosthetic (tissue) heart valve specifically engineered for use in the mitral position, a critical area for managing blood flow between the left atrium and left ventricle. The MITRIS RESILIA valve features advanced tissue preservation technology designed to improve durability and reduce calcification over time, making it a promising solution for patients requiring mitral valve replacement
- In January 2022, JenaValve Technology, Inc. formed a strategic partnership with Peijia Medical Limited, a leading medical device firm based in China, through a combination of equity investment and exclusive technology licensing. Under the terms of the agreement, Peijia made an initial financial investment and committed to ongoing support in exchange for exclusive development and commercialization rights to JenaValve’s Trilogy Transcatheter Aortic Valve Replacement (TAVR) system across the Greater China region. The Trilogy system is designed to treat patients with severe symptomatic aortic regurgitation or aortic stenosis—conditions that often require complex intervention
Frequently Asked Questions
These valves are increasingly preferred by patients and doctors due to faster recovery times and fewer post-operative complications, is emerging as a pivotal trend driving the global prosthetic heart valve market.
The major factors driving the growth of the global prosthetic heart valve market are growing need due to the rising global geriatric population is increasing cases of valvular disorders.
The primary challenges include high cost of prosthetic heart valves and related surgical procedures.
The transcatheter heart valve segment is expected to dominate the prosthetic heart valve market with the largest share of 62.05% in 2025 due to its minimally invasive nature, which offers quicker recovery times and reduced risk compared to traditional open-heart surgeries.
