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. Read More
CN Bio Ltd. launched the Physiomimix single-organ higher throughput system commercially in hopes it will foster the adoption of microphysiological systems which increase productivity, improve data quality and offer cost-effective solutions for drug discovery. Read More
Aquapass Medical Ltd. has readied a pre-submission plan for the FDA this month to advance technology designed to reduce hypervolemia or fluid overload in patients suffering from heart failure, kidney failure or lymphedema. Conjuring up images of an astronaut stepping out onto a NASA loading dock, the Microclimate Suit uses low humidity and fast flowing air on the patient’s skin to evaporate excess bodily fluids. The suit won FDA breakthrough device designation in December 2022. Read More
Tricuspid valve regurgitation has lagged mitral regurgitation where device development is concerned, but new one-year data from the TRILUMINATE study of the Triclip device suggests that device therapy is safe and cuts down on regurgitation in a manner that makes the condition much more tolerable for patients. At this point, however, the data do not yet offer much difference when it comes to mortality and rehospitalization compared to medical management, a gap Abbott will have to overcome if it wants to maximize its investment in this underdeveloped area of medical technology. Read More
Coloplast A/S is about to launch a new single-use male intermittent catheter featuring new technology designed to reduce the risk of urinary tract infections (UTI). “The Luja device, with its micro-hole zone technology, is going to drive future growth in our continence care division,” Coloplast Chief Financial Officer Anders Lonning Skovgaard told BioWorld.Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Edwards Lifesciences, Irhythm Technologies, Medtronic, Smith+Nephew, University of Miami. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Academy Medical, Bellaseno, Claria, Endonovo, Evonik, GI Reviewers, Interactive Digital, Invitae, RSIP Vision, Sophia Genetics, Venus Medtech, Veta Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Sooma. Read More
