Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation.

4C Medical Technologies Inc. raised $175 million in a series D financing round led by Boston Scientific Corp. The financing will support the regulatory trials and commercialization of the Altavalve system, a transcatheter mitral valve replacement (TMVR) technology.

Although there is a clear clinical need for transcatheter mitral valve replacement technologies, a number of challenges must be overcome before they can safely be used to treat patients with mitral regurgitation. Nevertheless, two new devices could enter the European market next year, Edwards Lifesciences Corp.’s Sapien M3 and Highlife Medical SAS’s Highlife TMVR device.