Business Wire

LivaNova Implements 3T Heater-Cooler Device Modification

Del

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.

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 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.

Contact information

LivaNova PLC Investor Relations and Media
Karen King, +1 (281) 228-7262
Vice President, Investor Relations & Corporate Communications
or
Deanna Wilke, +1 (281) 727-2764
Corporate External Communications Manager
Corporate.Communications@LivaNova.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Integral Expands Cryptocurrency Market Data Services to Include 14 Cryptocurrencies and 16 Exchanges23.1.2018 22:00Pressemelding

Integral (www.integral.com), the financial technology partner trusted by leading banks, brokers, and investment managers to design, deliver and grow their FX businesses, announced today that it has expanded its market data offering for cryptocurrencies to include 14 major cryptocurrencies connecting to all major exchange sources across the U.S., Europe and Asia including Japan and Hong Kong. “An accurate, stable, and reliable reference price is a requirement for any market maker,” said Harpal Sandhu, CEO of Integral. “The Cryptocurrency Market Data Service connects to the most price sources and applies the most advanced price discovery algorithm available.” Integral has years of experience as a technology leader and innovator in foreign exchange and is now applying this ingenuity to the cryptocurrency market. The Market Data Service uses algorithms developed with Stanford University for Integral FX Benchmark to provide the most precise reference prices for cryptocurrencies. “Integral’s

Kimbal Riley to Become Vista Group CEO23.1.2018 21:57Pressemelding

Vista Group International (NZX & ASX: VGL) has today announced that Kimbal Riley will take over as Group CEO from Murray Holdaway. Mr Holdaway will take up the position of Chief Product Officer (CPO) for Vista Group, and will continue in his role as an Executive Director on the Vista Group board. This has taken place as part of a succession planning process and will deliver a seamless transition within the business. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123006545/en/ Kimbal Riley becomes CEO of Vista Group International (Photo: Business Wire) Mr Riley has had an extensive career in senior executive roles in the IT and Services industries in New Zealand and overseas. He joined Vista Group four years ago, with the past two years as CEO of Vista Entertainment Solutions (VES), which is responsible for the largest proportion of the Group’s revenue. He has been focused on building scale in the business and under his lea

IFF Breaks Ground on Flavors/Fragrances Site in Sri City, India23.1.2018 17:00Pressemelding

Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF), a leading innovator of sensory experiences that move the world, has broken ground on a new flavors and fragrances plant located in Sri City, in the State of Andhra Pradesh in India. Part of a larger investment into the Greater Asia region, the plant is expected to be commercialized in December 2019. The new facility, which will be the largest flavor and fragrance manufacturing facility in India and the largest IFF site in Greater Asia, occupies a 32-acre/130,000m2 plot and will serve IFF flavors and fragrances customers across India and the region. “In this economically vibrant country, it is critical that we invest to provide our customers with winning tastes and scents,” said IFF Chairman and CEO Andreas Fibig. “This new facility is fitted with capabilities tailored for our customers’ needs. Coupled with our excellent consumer insights teams and their deep understanding of the local markets, w

Global Eagle to Elevate Airline Passenger Experience Over North America with More SES HTS Satellite Capacity23.1.2018 14:33Pressemelding

Global Eagle Entertainment Inc. (NASDAQ: ENT) is aiming to provide airline passengers travelling across North America with a connected inflight experience far more like the one passengers enjoy on the ground, tripling the amount of high throughput satellite (HTS) capacity secured with SES Networks aboard the SES-15 satellite. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123005989/en/ Global Eagle to Elevate Airline Passenger Experience Over North America with More SES HTS Satellite Capacity (Photo: Business Wire) SES announced today that Global Eagle has secured a major increase of Ku-band capacity on its new hybrid SES-15 HTS satellite to enable the delivery of high-speed broadband and a wide range of inflight communications and operational applications aboard commercial airline flights throughout the US, including the increasingly important US mainland to Hawaii routes. The multi-year agreement is the latest contract t

Optiv Security Names Simon Church as General Manager and Executive Vice President, Europe; Accelerates International Growth Strategy with Expansion in Europe23.1.2018 14:05Pressemelding

Optiv Security, a market-leading provider of end-to-end cyber security solutions, today announced it is continuing to accelerate its international growth strategy by naming Simon Church as general manager and executive vice president, Europe. In his newly created role, Church will establish and grow Optiv’s presence in Europe, enabling the company to serve locally-based organizations and global clients with expanded skills, knowledge and presence. Optiv serves more than 60% of the Fortune 1000, and this appointment will increase its ability to provide US and international clients with worldwide expertise and experience, assisting them in reducing the complexity of their cyber security programs while maximizing the efficacy and value of their security investments. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123005315/en/ Optiv Security Names Simon Church as General Manager and Executive Vice President, Europe; Accelerate

LEGO® Education Launches New Maker Activities for Schools23.1.2018 14:00Pressemelding

LEGO® Education Maker, a continuum of activities for early learning through middle school, is available today to schools around the world. The activities are centered around the iconic LEGO brick and inspired by the open-ended, playful creativity of making. The new, free LEGO Education Maker activities include stimulating challenges for every student at every education level and incorporate LEGO Education solutions including LEGO Education STEAM Park, LEGO Education Simple Machines, LEGO Education WeDo 2.0, LEGO® MINDSTORMS® Education EV3 and LEGO Education Simple and Powered Machines. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123005927/en/ LEGO® Education Launches New Maker Activities for Schools (Photo: Business Wire) New LEGO Education Maker activities provide unlimited learning for all ages The new LEGO Education Maker activities place educators in the role of facilitators, as they guide their students through a s

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom