Pulsed field ablation (PFA) may not be the final word where energy sources for atrial fibrillation (AF) ablation are concerned, but several companies have adopted development programs that propose the use of PFA as an alternative to conventional energy sources. Dublin-based Medtronic plc appears to have at least a narrow lead over the competition in the PFA space thanks to the results of the PULSED AF pivotal study presented at the 2023 American College of Cardiology Scientific Sessions.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Coherus, Neuromod Devices, X-Bolt.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Auxocell, Biostem, Caredx, Caris Life Sciences, Electrocore, Fulton Ventures, Incyte, KLS Martin, Lucius Partners, Mellingmedical, Miach Orthopaedics, PD Theranostics, Rocket VR Health.
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.
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.
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.
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.
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