FDA OKs LivaNova’s 3T Heater-Cooler Device Modification

LivaNova PLC received U.S. Food and Drug Administration (FDA) 510(k) clearance for a device modification to its 3T Heater-Cooler devices. The modification includes the installation of a 3T Aerosol Collection Set, as well as testing that demonstrates the effectiveness of its operating instructions. This modification has been implemented at no cost to customers on devices that have already been distributed and is being implemented on new units being prepared for distribution. Collectively, these modifications further reduce the potential risk of possible dispersion of aerosols in hospital operating rooms when used in accordance with Operating Instructions. Devices manufactured in accordance with this newly cleared 510(k) will not be subject to the current FDA import alert.
 
Through past and present field actions, LivaNova has been implementing the design modification on devices in the field throughout the U.S since October 2018. In connection with a product remediation plan that was announced in early 2017, the company continues to make available to U.S. customers its 3T device loaner program, as well as a no-charge deep cleaning service for any 3T device with confirmed M. chimaera contamination. In other locations around the world, the Company has been successfully cleaning 3T Heater-Cooler devices and implementing the modification since receiving CE mark in 2017.
 
“FDA clearance allows us to implement a permanent design solution for 3T Heater-Cooler devices used in the U.S. that further mitigates the potential risk of aerosolization,” said Bryan Olin, LivaNova Senior Vice President for Clinical, Quality and Regulatory Affairs. “Heater-coolers are critical pieces of equipment for open-heart surgery, and LivaNova wants to ensure continued access to these important devices for the ongoing treatment of patients around the world.”