|LivaNova Implements 3T Heater-Cooler Device Modification|
LONDON--(BUSINESS WIRE)--LivaNova PLC (NASDAQ:LIVN) (together with its subsidiaries as "LivaNova" or the "Company"), a market-leading medical technology company, today announced the implementation of a device modification to its existing 3T Heater-Cooler devices in Western Europe. During the past fiscal quarter, LivaNova successfully completed verification and validation processes, which allowed the Company to obtain CE Mark for its 3T Heater-Cooler device modification. It began implementing upgrades in Europe and implementation will extend to other regions as local regulatory approvals are received. The modification, which is being implemented at no cost to customers, includes the installation of an internal sealing and vacuum system on existing devices. This addresses regulatory actions and is designed to mitigate the potential for Mycobacterium chimaera (M. chimaera) contamination in open-heart surgery patients.
"We are pleased to be rolling out our 3T Heater-Cooler design modification in numerous countries, which is intended to be the permanent design solution that addresses the issue of aerosolization," said Jim Trevor, LivaNova's Senior Vice President for 3T Heater-Cooler devices. "Care for our patients and the quality of our products are at the forefront of everything we do. We want to ensure safe, continued access to this important device that enables lifesaving cardiac surgery."
LivaNova will implement the design modification on existing devices in the field, as one part of a three-part device remediation plan to address the important industry-wide issue concerning the use of heater-coolers during open-heart surgery. Another part of this plan is LivaNova's no-charge deep disinfection service for 3T Heater-Cooler users who have reported confirmed M. chimaera contamination. The deep disinfection service is available in many countries around the world, but not yet in the United States where the Company is reviewing the regulatory pathway for implementation with FDA. All devices receiving deep disinfection also receive the device modification before being placed back in use. The third part of the plan is the Company's loaner program, initiated in fourth quarter 2016, under which existing 3T Heater-Cooler users are loaned a new 3T Heater-Cooler device at no charge. 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. It will remain an integral part of the remediation plan until the device modification and deep disinfection services are approved for use worldwide.
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 more than 4,500 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.
Safe Harbor Statement
Certain statements in this press release contain "forward-looking statements" relating to implementation of our 3T Heater-Cooler device modification. Such statements are based on information presently available to us and assumptions that we believe to be reasonable. Investors are cautioned that all such statements are subject to risks, uncertainties and other important factors, many of which are beyond our control, that could cause our actual performance to differ materially from the forward-looking statements contained in this press release, including those described in the "Risk Factors" section of Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, the Registration Statement on Form S-4 and other documents filed from time to time with the United States Securities and Exchange Commission by LivaNova.
All information in this press release is as of the date of its release. The Company does not undertake or assume any obligation to update publicly any of the forward-looking statements in this press release to reflect new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this press release.
LivaNova PLC Investor Relations and Media