B Braun has revealed that 12-month results from the LOCOMOTIVE EXTENDED study of the company’s Multi-Loc multiple stent delivery system have been published in Vasa: European Journal of Medicine. The study authors, Klaus Amendt (Diakonissenkrankenhaus Mannheim, Mannheim, Germany) and colleagues conclude that the Multi-Loc “provides promising results concerning target lesions revascularisation and primary patency at 12 months”.
LivaNova has entered into an agreement with investment firm Gyrus Captial whereby entities funded and controlled by Gyrus will acquire the LivaNova heart valve (HV) business.
Baylis Medical has announced the publication of data demonstrating procedural efficiency for MitraClip transcatheter mitral valve repair (TMVR) with use of its VersaCross RF Transseptal device, reporting guide delivery from femoral access in under 7.5 minutes.
Gore has announced encouraging clinical results from its early feasibility study evaluating the safety and performance of its pulmonary valved conduit, an investigational device. Six-month data for 16 patients enrolled across three sites in the USA were presented in a moderated poster session during the American Heart Association virtual scientific sessions (AHA 2020, 13 – 17 November, virtual).
Emerging data supports transcatheter techniques to treat primary mitral regurgitation, according to KK Yeo (National Heart Center, Singapore) who presented at PCR Valves 2020 (22–24 November, virtual) discussing the latest developments in edge-to-edge repair for primary mitral regurgitation.
MedAlliance has announced completion of patient enrolment in the ISABELLA clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of dysfunctional arteriovenous (AV) fistulas in end-stage renal failure patients undergoing haemodialysis.
The first randomised trial comparing a course of pre-procedure percutaneous coronary intervention (PCI) versus no PCI in patients undergoing transcatheter aortic valve implantation (TAVI) with significant coronary artery dieseae (CAD) found no difference in the primary endpoints of death or rehospitalisation at one-year follow-up between the two treatment strategies.
Discussion during the first day of the PCR Valves e-course (22–24 November, virtual) centred on the aortic valve and sought to answer key questions over the latest clinical evidence on transcatheter aortic valve implantation (TAVI) in low-risk patients, as well as probing the decision-making process guiding the choice between transcatheter or surgical approaches to aortic stenosis.
A study published in ACS Biomaterials Science & Engineering details the development of a 3D-printed, full-size model of a human heart, that could be used to train surgeons preparing for surgical procedures in the heart. Authored by Eman Mirdamadi and colleagues from the Department of Biomedical Engineering, Carnegie Mellon University (Pittsburgh, USA), the study details the use of Freeform Reversible Embedding of Suspended Hydrogels (FRESH) bioprinting to develop a human heart model from patient-derived magnetic resonance imaging (MRI) datasets.
Corvia has announced completion of randomisation in its REDUCE LAP-HF II global, pivotal trial. The trial is evaluating the Corvia atrial shunt (IASD)—a novel, transcatheter implant—to reduce elevated left atrial pressures (LAP), the primary cause of HF symptoms, in heart failure patients with preserved ejection fraction (HFpEF) or mid-range ejection fraction (HFmrEF). The company also announced authorisation by the US Food and Drug Administration (FDA) to continue evaluation of the Corvia Atrial Shunt under a Continued Access Protocol (CAP) while its pre-market approval (PMA) application is under review. PMA submission is planned for late 2021.
Boston Scientific has announced a global recall of all unused inventory of its Lotus Edge transcatheter aortic valve implantation (TAVI) system due to complexities associated with the product delivery system.
Sinomed has announced the presentation of data from its inter-continental PIONEER III study comparing the safety and efficacy of the Supreme HT (healing-targeted) drug-eluting stent (DES), to the Xience (Abbott) or Promus durable polymer stent (Boston Scientific). One-year results were presented during a late-breaking trial session at the American Heart Association 2020 scientific sessions (AHA 2020, 13–17 November, virtual). The data showed equivalent clinical performance of the Supreme HT to the market-leading DES and will be used to support US Food and Drug Administration (FDA) and Japanese regulatory approvals.
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