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.”