Key Developments

In October 2023, Edwards Lifesciences Corporation, the global leader in patient-focused technologies for structural heart disease, announced that its EVOQUE tricuspid valve replacement system has acquired CE Mark for transcatheter treatment of eligible patients with tricuspid regurgitation (TR). The EVOQUE system is the world's first transcatheter valve replacement therapy to be approved by regulators for TR treatment.
In March 2023, Abbott, a medical company, announced that the U.S. Food and Drug Administration (FDA) has approved the Epic Max stented tissue valve for the treatment of aortic regurgitation and stenosis. This device is the most recent addition to Abbott's Epic surgical valve platform, which has a decades-long track record of safety and excellent clinical outcomes, and it features an improved design to boost valve blood flow even further.
In November 2022, Nyra Medical, Inc., a medical device company developing a revolutionary transcatheter mitral valve repair technology, announced the completion of a US$ 20 million Series A fundraising. Vensana Capital and a significant global medical device business co-led the round, with additional investors including Broadview Ventures, Epidarex Capital, and the Georgia Research Alliance Venture Fund. The proceeds from the financing will be utilized to advance Nyra Medical, Inc.’s technology through early feasibility trials.
In September 2022, Edwards Lifesciences announced the launch of SAPIEN 3 Ultra RESILIA valve, which combines the company’s innovative RESILIA tissue technology with the industry-leading SAPIEN 3 Ultra transcatheter aortic heart valve. The rollout follows recent U.S. FDA approval.