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.

Edwards Lifesciences Corp. made a splash recently with the U.S. FDA approval of the Evoque tricuspid valve replacement device, but is also pressing Centers for Medicare and Medicaid Services to provide a coverage framework for this class of devices.

Edwards Lifesciences Corp. said it has exercised its option to buy Innovalve Bio Medical Ltd., an early stage transcatheter mitral valve replacemen company, for $300 million in cash following its initial investment in 2017. Since that time, Edwards said Innovalve has demonstrated progress in its program with promising early clinical experience.

Edwards Lifesciences Inc. struck three deals totaling €15 million (US$16.3 million) with Affluent Medical SAS to gain access to its mitral valve technology. Edwards secured an exclusive option to acquire Affluent subsidiary Kephalios, which makes the Kalios adjustable mitral ring, for €5 million (US$5.44 million); paid €5 million more for global, non-exclusive licensing of Affluent’s intellectual property related to its biomimetic cardiac mitral valve replacement technology; and invested a further €5 million to acquire 9.21% of Affluent.

Cardiomech AS raised $13 million in fresh capital via a convertible loan agreement that will go towards developing its transcatheter mitral valve chordal repair technology. The round was heavily oversubscribed, indicating investors' expectations that the company’s technology may be a first-line therapy for patients suffering from degenerative mitral regurgitation.

Innovheart srl has landed more than $55 million to continue clinical trials of its transcatheter mitral valve replacement (TMVR) system for the treatment of mitral valve disease. The series C equity round was led by Grand Pharmaceutical Group Ltd. (Grand Pharma), together with existing investors Genextra, Panakes Partners and Indaco Venture Partners.

Abbott Laboratories has received CE mark approval for its Tendyne transcatheter mitral valve implantation (TMVI) system, the first such device approved for use in Europe and the world. The system is intended for patients with leaky mitral valves that are beyond repair and those at high risk for open heart surgery.

While the U.S. Centers for Medicare and Medicaid Services (CMS) revisits its coverage policy for transcatheter mitral valve repair devices, several physician societies have drafted recommendations for operator and institutional volume requirements that could restrict the number of centers authorized to practice devices such as Abbott Park, Ill.-based Abbott Laboratories’ Mitraclip.