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BioWorld - Saturday, June 7, 2025
Home » Topics » Medical devices » Pacemaker

Pacemaker
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omniasecure defib lead
HRS 2024

Omniasecure defibrillation lead exceeds LEADR performance goals

May 17, 2024
By Holland Johnson
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.
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Cairdac's device

Cairdac raises $18.5M in funding to develop self-powering leadless pacemaker

April 18, 2022
By Bernard Banga
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.
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Aveir DR dual-chamber leadless pacemaker

Abbott initiates pivotal trial for Aveir for leadless dual-chamber pacing

Feb. 11, 2022
By Mark McCarty
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.
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Cysoni device

New bionic pacemaker boosts cardiac performance in preclinical studies

Feb. 10, 2022
By Catherine Longworth
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.
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Medtronic-Micra-11-12.png

FDA wary of risk of perforation associated with Medtronic’s Micra leadless pacemaker

Nov. 19, 2021
By Mark McCarty
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.
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EBR wins breakthrough designation from FDA for its wireless pacemaker

Sep. 11, 2019
By Meg Bryant

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