LivaNova PLC (NASDAQ:LIVN) Files An 8-K Other EventsItem 8.01 Other Events
LivaNova PLC (NASDAQ:LIVN) Files An 8-K Other Events
In respect of its consolidated financial statements as of and for the year ended December 31, 2016, LivaNova PLC (the “Company”) has recognized a liability 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 incurred during the twelve month period ended December 31, 2016, the Company also recognized a $33.5 million liability at December 31, 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.
About LivaNova PLC (NASDAQ:LIVN)
LivaNova PLC is a medical technology company. The Company operates through three segments: Cardiac Surgery, Cardiac Rhythm Management (CRM) and Neuromodulation. The Cardiac Surgery business unit is engaged in the development, production and sale of cardiovascular surgery products, including oxygenators, heart-lung machines, perfusion tubing systems and systems for autotransfusion and autologous blood washing. The CRM business unit develops, manufactures and markets products for the diagnosis, treatment and management of heart rhythm disorders and heart failure. CRM offers products, including leads and delivery systems, and information systems. The Neuromodulation business unit designs, develops and markets neuromodulation-based medical devices for the treatment of epilepsy and depression. Through the Neuromodulation business unit, the Company markets its implantable VNS Therapy systems that deliver vagus nerve stimulation therapy for the treatment of epilepsy and depression. LivaNova PLC (NASDAQ:LIVN) Recent Trading Information
LivaNova PLC (NASDAQ:LIVN) closed its last trading session up +0.50 at 50.40 with 393,638 shares trading hands.
LivaNova PLC is a medical technology company. The Company operates through three segments: Cardiac Surgery, Cardiac Rhythm Management (CRM) and Neuromodulation. The Cardiac Surgery business unit is engaged in the development, production and sale of cardiovascular surgery products, including oxygenators, heart-lung machines, perfusion tubing systems and systems for autotransfusion and autologous blood washing. The CRM business unit develops, manufactures and markets products for the diagnosis, treatment and management of heart rhythm disorders and heart failure. CRM offers products, including leads and delivery systems, and information systems. The Neuromodulation business unit designs, develops and markets neuromodulation-based medical devices for the treatment of epilepsy and depression. Through the Neuromodulation business unit, the Company markets its implantable VNS Therapy systems that deliver vagus nerve stimulation therapy for the treatment of epilepsy and depression. LivaNova PLC (NASDAQ:LIVN) Recent Trading Information
LivaNova PLC (NASDAQ:LIVN) closed its last trading session up +0.50 at 50.40 with 393,638 shares trading hands.
