In a real-world study, Eko Health Inc.’s AI-enabled digital stethoscope dramatically increased detection rates for atrial fibrillation, heart failure and valvular heart disease in primary care settings. Researchers from Imperial College London presented results from the study at the European Society of Cardiology in Madrid.
Abbott Laboratories recently received FDA clearance for Tendyne, its transcatheter mitral valve replacement system. The news comes on the heels of Edwards Lifesciences Corp. securing a CE mark for its Sapien M3 system and is a boon for mitral valve therapies amid ongoing frustrations about the slow adoption of TMVR technologies.
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.
Medtronic plc and Tempus AI Inc. launched the ALERT study to better understand and address the racial, ethnic, gender and geographic disparities associated with guideline-recommended treatments for aortic stenosis and mitral valve regurgitation. Currently, white patients represent 91% of people who receive TAVR procedures, a minimally invasive procedure that sharply reduces complications and improves quality of life in patients with narrowed heart valves.
Hope for definitive resolution of the controversy about the superiority of transcatheter edge-to-edge repair of mitral valves over medical therapy in individuals with symptomatic heart failure and functional mitral regurgitation were dashed at the European Society of Cardiology meeting this weekend.
Abbott Laboratories scored a major win for its Mitraclip device thanks to data from the COAPT study for secondary mitral valve regurgitation. The latest data from this study show a stunning difference in two-year mortality compared to maximized medical management only – 29% on the device versus 46% on medical management – but differences between the COAPT study results and outcomes seen in the MITRA-FR study will force cardiologists to dive into the data to ensure that their patient selection practices account for critical differences in the conduct of these two studies.
Structural heart startup Nyra Medical Inc. scooped up $20 million in a series A round co-led by Vensana Capital and a large, unnamed global medical device company. The funds will be used to advance Nyra’s transcatheter heart valve repair technology through early feasibility clinical studies.
Cardiac Dimensions Inc. launched the Empower trial of its Carillon mitral contour system for the treatment of heart failure patients with early-stage functional mitral regurgitation. The company expects to enroll up to 300 patients at 75 sites in the international, randomized, sham-controlled trial.
Vivasure Medical Ltd. has designed a sutureless and absorbable venous vessel closure for use following percutaneous cardiovascular procedures, such as transcatheter mitral valve or tricuspid valve repair or replacement. The Perqseal Blue technology builds on the Galway, Ireland-based company’s Perqseal, which received the CE mark for vascular closure of femoral arteries in 2016.
