- In May 2024, Medtronic plc received expanded FDA approval for its Evolut FX TAVR system to include intermediate-risk patients with aortic stenosis. This regulatory milestone reflects the growing clinical confidence in transcatheter aortic valve replacement technologies and underscores Medtronic’s leadership in advancing less invasive solutions for structural heart disease. The approval is expected to significantly broaden patient access and further accelerate the global adoption of TAVR procedures
- In March 2024, Edwards Lifesciences Corporation launched the next-generation SAPIEN X4 transcatheter heart valve system in Europe following CE Mark approval. The device introduces enhanced frame design, improved durability, and precise delivery features aimed at optimizing outcomes in aortic valve replacement. This development represents Edwards’ continued investment in innovation to meet evolving clinical needs and reinforces its leading position in the global TAVR segment
- In February 2024, Abbott Laboratories announced promising clinical trial results for its TriClip device, a transcatheter solution for tricuspid valve repair. The TRILUMINATE trial demonstrated significant improvement in heart failure symptoms and quality of life among patients with tricuspid regurgitation. These findings are expected to pave the way for regulatory approvals and drive commercial adoption, marking a significant expansion of transcatheter therapies beyond the aortic and mitral positions
- In January 2024, Boston Scientific Corporation completed the acquisition of Millipede, Inc., a company specializing in transcatheter mitral valve repair technology. The acquisition enables Boston Scientific to strengthen its structural heart portfolio and positions the company to compete in the growing market for minimally invasive mitral interventions. This strategic move aligns with the industry trend toward comprehensive transcatheter solutions
- In December 2023, JenaValve Technology, Inc. announced the successful enrollment of its ALIGN-AR pivotal trial for the JenaValve Pericardial TAVR System, targeting patients with symptomatic aortic regurgitation. As one of the few TAVR systems designed specifically for pure AR cases, this innovation addresses a critical unmet need and has the potential to open a new segment within the transcatheter valve market. JenaValve’s continued progress highlights the market’s shift toward condition-specific device development
