https://www.bioworld.com/rss en-us holland.johnson@clarivate.com Medtronic plc said its investigational Omniasecure defibrillation lead met its primary safety and effectiveness endpoints and exceeded prespecified performance goals, in the global Lead Evaluation for Defibrillation and Reliability (LEADR) pivotal trial. http://www.bioworld.com/articles/708281 Fri, 17 May 2024 12:00:00 -0400 https://www.bioworld.com/articles/708281-omniasecure-defibrillation-lead-exceeds-leadr-performance-goals omniasecure defib lead Omniasecure defibrillation lead. Credit: Courtesy Medtronic plc Cairdac SAS closed its first funding round, raising nearly $18.5 million to increase development of an autonomous, leadless pacemaker transcatheter system (ALPS) powered entirely using kinetic energy from the heart. Five French private equity funds and banks participated in this series A round. http://www.bioworld.com/articles/517988 Mon, 18 Apr 2022 13:00:00 -0400 https://www.bioworld.com/articles/517988-cairdac-raises-185m-in-funding-to-develop-self-powering-leadless-pacemaker Cairdac's device Cairdac’s self-powering pacemaker transforms kinetic energy from the heart into electrical energy. Credit: Cairdac SAS Abbott Laboratories reported the commencement of a pivotal clinical trial for its Aveir pacemaker in a two-device configuration to provide dual-chamber pacing without the need for leads to deliver the charge. This configuration required the development of i2i technology to ensure that the two Aveirs communicated in a manner that ensures consistent pacing, but the 500-enrollee study has a long road ahead of it before the company can finalize the application with the FDA. http://www.bioworld.com/articles/516008 Fri, 11 Feb 2022 13:00:00 -0500 https://www.bioworld.com/articles/516008-abbott-initiates-pivotal-trial-for-aveir-for-leadless-dual-chamber-pacing Aveir DR dual-chamber leadless pacemaker Abbott's investigational Aveir is designed to provide synchronous, beat-by-beat pacing of the right atrium and right ventricle of the heart. Credit: Abbott Laboratories A bioelectronic device developed by U.K. startup Ceryx Medical Ltd. has shown potential to restore cardiac performance in preclinical studies. The Cardiff, Wales-based company published data showing its Cysoni technology increased cardiac output by 20% compared to current pacemakers. http://www.bioworld.com/articles/515962 Thu, 10 Feb 2022 13:00:00 -0500 https://www.bioworld.com/articles/515962-new-bionic-pacemaker-boosts-cardiac-performance-in-preclinical-studies Cysoni device Cysoni bionic pacemaker. Credit: Ceryx Medical Ltd. Dublin-based Medtronic plc’s Micra pacemaker was a groundbreaking device when the FDA approved the leadless pacemaker in 2016, thanks to the elimination of the hazards associated with pacemaker leads. However, the FDA said recently that the risks associated with cardiac perforation with leadless pacemakers, such as tamponade or death, might be higher with the Micra than with pacemakers with leads. http://www.bioworld.com/articles/513572 Fri, 19 Nov 2021 13:00:00 -0500 https://www.bioworld.com/articles/513572-fda-wary-of-risk-of-perforation-associated-with-medtronics-micra-leadless-pacemaker Medtronic-Micra-11-12.png Micra device. Credit: Medtronic plc http://www.bioworld.com/articles/430405 Wed, 11 Sep 2019 00:00:00 -0400 https://www.bioworld.com/articles/430405-ebr-wins-breakthrough-designation-from-fda-for-its-wireless-pacemaker