LivaNova Plc – Product remediation plan related to 3T Heater Cooler device
In respect of its consolidated financial statements under US GAAP as of and for the year ended 31 December 2016, LivaNova PLC (the “Company”) has recognized a liability under US GAAP in the amount of $33.5 million for a product remediation plan related to its 3T Heater Cooler device. The remediation plan developed by the Company consists primarily of a modification of the 3T Heater Cooler design to include internal sealing and the addition of a vacuum system to new and existing devices. These changes are intended to address regulatory actions and further reduce the risk of possible dispersion of aerosols from the 3T Heater Cooler device in hospital operating rooms. The deployment of this solution for commercially distributed devices will commence upon final validation and verification of the design changes and approval or clearance by regulatory authorities worldwide.
As part of this plan, the Company also intends to implement a no-charge deep disinfection service for 3T Heater Cooler users who have reported confirmed M. chimaera mycobacterium contamination. The Company anticipates expanding the deep disinfection service globally as regulatory approvals are received.
Finally, in the fourth quarter of 2016 the Company initiated a program to loan existing 3T Heater Cooler users a new 3T Heater Cooler device at no charge pending regulatory approval and implementation of the vacuum system addition and deep disinfection service worldwide. This loaner program began in the United States and is being made available progressively on a global basis, prioritizing and allocating devices to 3T Heater Cooler users based on pre-established criteria.
In addition to $4.0 million of costs under US GAAP incurred during the twelve month period ended December 31, 2016, the Company also recognized a $33.5 million liability under US GAAP at 31 December 2016. These costs all relate to the execution of the remediation plan, including (i) finalization and implementation of the design change, (ii) provision of deep disinfection services, and (iii) the provision of loaner 3T Heater Cooler devices.
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London and with a presence in more than 100 countries worldwide, the company employs approximately 4,600 employees.
LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm Management, with operating headquarters in Mirandola (Italy), Houston (U.S.A.) and Clamart (France), respectively.
For more information, please visit www.livanova.com or contact:
Phone: +44 (0) 203 325 0662
Vice President, Investor Relations & Corporate Communications
Phone: +1 (281) 228-7262