LivaNova Implements 3T Heater-Cooler Device Modification
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
Karen King, +1 (281) 228-7262
Vice President, Investor Relations & Corporate Communications
Deanna Wilke, +1 (281) 727-2764
Corporate External Communications Manager
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Seoul Semiconductor’s SunLike Series LEDs Win Product of the Year Award from Elektronik Magazine23.3.2018 21:28 | Tiedote
Seoul Semiconductor, a global innovator of LED products and technology, announced on March 23rd that its SunLike Series natural spectrum LED product won the Gold Award at the Elektronik Product of the Year 2018 Awards, hosted by Elektronik (http://www.elektroniknet.de), a leading German electronics publication. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180323005646/en/ Product of the Year Award from Elektronik Magazine (SunLike) (Photo: Business Wire) As a publication specializing in electrical and electronic components, “Elektronik” is a prestigious magazine with an illustrious history and the largest number of subscribers in Germany. Over the past 20 years, they have conducted annual surveys among their subscribers to find the “most creative and innovative products.” Based on these survey results, Elektronik selects the top product that with the most impact in its corresponding field, and confers the awards accordingl
Elliott Welcomes Imminent Bezeq Board Overhaul and New Era for Strong Independent Governance23.3.2018 19:05 | Tiedote
Elliott Advisors (UK) Limited (“Elliott”), which advises funds which collectively hold a significant economic interest in Bezeq The Israeli Telecommunication Corporation Ltd. (“Bezeq” or the “Company”), welcomes the proposed governance reforms announced by Bezeq last night. In its initial letter to Bezeq Interim Chairman David Granot, dated January 16, 2018, Elliott outlined the urgent need to address the Company’s serious corporate governance issues, and called for changes at the Board level that result in “the right mixture of expertise, independence and integrity for the future.” Elliott stated then, and reiterates now, its belief that “there is significant value to be unlocked if the right steps are taken to improve its corporate governance.” Bezeq has strong business fundamentals, an exemplary workforce, and great potential. Following yesterday’s announcement, Elliott highlights the changes that have occurred since January 16th. Taken together, these amount to a revolution in the
Clovis Oncology Initiates Early Access Program for Rucaparib as Treatment and as Maintenance Therapy in Recurrent Ovarian Cancer in Europe23.3.2018 15:52 | Tiedote
Clovis Oncology, Inc. (NASDAQ:CLVS) today announced the initiation of an early access program in Europe for rucaparib for treatment and as maintenance therapy in recurrent ovarian cancer. The program will be overseen and implemented by Caligor Coghlan, which specializes in early access to medicines. The program, to be known as the Rucaparib Access Program (RAP), will enable participation from certain countries in Europe, where permitted by applicable rules, procedures and regulatory authorities. The RAP protocol allows for rucaparib treatment of an individual patient with third-line or greater BRCA mutant epithelial, fallopian tube, or primary peritoneal ovarian cancer who has platinum-sensitive disease and is unable to tolerate further platinum-based chemotherapy or has platinum-resistant disease and needs treatment with single agent rucaparib. The RAP protocol will also provide access to rucaparib for maintenance therapy of an individual patient with recurrent epithelial ovarian, fal
CHMP Grants Positive Opinion for Clovis Oncology’s Rubraca® (rucaparib) Tablets23.3.2018 15:50 | Tiedote
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a conditional marketing authorization for Rubraca as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy. The European Marketing Authorization application for the treatment indication was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA mutant ovarian cancer who had progressed after two or more prior chemotherapies. “The recommendation
Janssen Announces Positive CHMP Opinion for JULUCATM▼ (dolutegravir/rilpivirine)23.3.2018 15:46 | Tiedote
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for JULUCA™ (dolutegravir 50mg [ViiV Healthcare UK Ltd]/rilpivirine 25mg [Janssen Sciences Ireland UC]). Dolutegravir/rilpivirine is a single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI).1 “We are delighted to be one step closer to bringing JULUCA™ to people living with HIV in Europe,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. “Building on our 25-year c
Aitheon Executives Educate World Leaders on Benefits, Challenges of AI at the Annual World Government Summit in Dubai23.3.2018 15:00 | Tiedote
Aitheon, makers of the world’s first blockchain-powered platform to solve real problems by integrating AI, robotics, IoT, human specialists and cryptocurrency, announced today that executives from the company held a series of high-level briefings with world leaders at the Annual World Government Summit in Dubai. Briefings covered the benefits and challenges of AI, and revolutionary new solutions to world challenges made possible by transformative new technologies. (Read the full release at www.aitheon.com/news) This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180323005269/en/ Aitheon founder and CEO, Andrew Archer, and Chief Strategy Officer, Ryan Burleson, were invited to brief leaders at the Summit by Cyrus Hodes, Co-founder and Director of the AI Initiative, an undertaking of the Future Society at Harvard University’s Kennedy School. Archer and Burleson addressed a variety of AI-related topics, including the impact of AI on
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme