LivaNova PLC LivaNova Plc - Product remediation plan related to 3T Heater Cooler device.
March 01 2017 - 6:30AM
UK Regulatory
TIDMLIVN
RNS - LivaNova Plc - Product remediation plan related to 3T
Heater Cooler device
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION.
1 March 2017
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.
About LivaNova
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:
Catherine Moroz
Company Secretary
Phone: +44 (0) 203 325 0662
e-mail: company.secretariat@livanova.com
Karen King
Vice President, Investor Relations & Corporate
Communications
Phone: +1 (281) 228-7262
Email: corporate.communications@livanova.com
View source version on businesswire.com:
http://www.businesswire.com/news/home/20170301005699/en/
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March 01, 2017 06:30 ET (11:30 GMT)
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