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LivaNova was formed from the merger of cardiovascular disease therapy company Sorin Group and neuromodulation innovator Cyberonics. The role and place in the industry of this new mega group might not be obvious to all, but incoming CEO Damien McDonald already has a vision of creating a disciplined company that leverages synergies and gets closer to the customer base.
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions over the past month. This edition takes a closer look at Respicardia, which has cut short the post-approval study of its implantable sleep apnea device study.
The Circulatory System Devices advisory panel generally recommends more frequent cleaning of the devices used to support open-chest surgery and, in the long term, it tasks manufacturers with redesigning them so they are easier to clean and disinfect.
The agency has issued a safety alert on the risk of bacterial infections linked to the use of LivaNova/Sorin's heater-cooler units during open-chest surgery, and held an advisory panel meeting last week to discuss strategies to better ensure safety of these and similar devices.
- Implantable Devices
Surgical Equipment & Devices
- Minimally or Less Invasive