Business Wire

LivaNova Implements 3T Heater-Cooler Device Modification

Jaa

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

Tietoja julkaisijasta

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 tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Celltrion Receives Positive CHMP Opinion for Herzuma® for Trastuzumab Biosimilar16.12.2017 01:13Tiedote

Celltrion, Inc. (KOSDAQ: 068270) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that Herzuma® (trastuzumab biosimilar) be granted marketing authorization in the European Union (EU) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The CHMP’s opinion will now be sent to the European Commission (EC) for final review. Herzuma® is a biosimilar to Herceptin®i, a breast cancer and gastric cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. Herceptin® is a blockbuster drug which had worldwide sales of CHF 6.8 billionii (US$6.8 billion) in 2016, of which CHF 2.1 billioniii (US$2.1 billion) was in

Takeda and TiGenix announce that Cx601 (darvadstrocel) has received a positive CHMP opinion to treat complex perianal fistulas in Crohn’s disease15.12.2017 15:34Tiedote

Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) and TiGenix NV (Euronext Brussels and NASDAQ: TIG) (“TiGenix”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has adopted a positive opinion recommending a marketing authorization (MA) for investigational compound Cx601 (darvadstrocel). Cx601 is expected to be indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.2 This recommendation marks the first allogeneic stem cell therapy to receive a positive CHMP opinion in Europe. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/201712

Bitcoin Romania and Twispay Announce Integration Partnership Providing Users with the Ability to Purchase Bitcoin with Bank Cards15.12.2017 15:21Tiedote

Bitcoin Romania, leading Eastern European Bitcoin exchange & brokerage firm, and Twispay, Swiss-owned European payment processor and FinTech pioneer, today announced the availability of a payment integration that allows a global clientele to acquire Bitcoin and Ethereum cryptocurrencies using Visa and Mastercard bank cards. Unprecedented in Romania, this is one of the first East-Central European integration partnerships that allow consumers to use their cards to purchase cryptocurrency. Until recently, investors could only acquire cryptocurrencies through bank transfers and cash deposits, but the volatility of cryptocurrency markets dictates the need for additional operational flexibility. Investors require faster, safer, more reliable, and more comfortable ways to complete purchases. “One minute can make the difference between a million lost and a million earned. That is pr

Upon Conclusion of the Fourth Annual Forum for Promoting Peace in Muslim Societies, Scholars and Intellectuals Visit the Louvre Abu Dhabi Museum15.12.2017 14:38Tiedote

A high-level delegation of dignitaries, scholars and intellectuals participating in the fourth annual Forum for Promoting Peace in Muslim Societies, visited the Louvre Abu Dhabi museum. The delegation was headed by H.E Mustafa Ceric, former Grand Mufti of Bosnia; alongside Sheikh Mohammad Mukhtar Ould Imbala, Head of Mauritania’s Fatwa & Grievances Supreme Council; H.E Amar Mirghani Hussein, Sudanese Minister of (religious) Guidance and Endowments; and H.E Salho Jay, Imam of the Juma Masjid in South Africa. The Forum was held in Abu Dhabi from 11-13 December 2017, with the participation of more than 700 scholars, intellectuals and religious dignitaries from around the world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171215005255/en/ Group Photo of the Scholars and Intellectuals during their visit to the L

Kennedy Wilson Acquires 124-Unit Northbank Apartments in Dublin, Ireland for €45 Million15.12.2017 14:00Tiedote

Global real estate investment company Kennedy Wilson (NYSE: KW) announces that it has acquired Northbank Apartments, a wholly-owned 124-unit apartment community in Dublin’s North Docks, for €45 million from Jarmar Properties Limited (In Receivership) acting through David Carson of Deloitte as Statutory Receiver, the lender being the National Asset Management Agency (“NAMA”). Situated in Dublin’s North Docks, Northbank is located just 50 meters from Kennedy Wilson’s existing 84-unit Liffey Trust apartments. The two buildings benefit from great transport links as the LUAS Red line is immediately adjacent connecting to Dublin’s city centre and main train stations in five minutes. “The successful acquisition of Northbank in such close proximity to our Liffey Trust asset allows us to leverage our existing presence and implement our value-add asset management strategy, including a

AML BitCoin Enters Phase II of ICO15.12.2017 12:00Tiedote

NAC Foundation, LLC announces today that the initial coin offering for the AML BitCoin – the world’s only patent-pending compliant digital currency – has been extended for another month to accommodate a torrent of last minute, new coin purchasers and the demands of thousands of current owners of the coin, who have had difficulty navigating the process of establishing the specialized wallet required to hold the innovative digital currency. This second phase of the AML BitCoin initial coin offering will see an increase in the price of the coin, from US $1.00 to US $1.25. The company has already been contacted by prospective purchasers in the slightly higher priced Phase II, and anticipates a further price increase to US $1.50 within a week or two. HitBTC, one of the world’s largest and most active digital currency exchanges, was prepared to list the AML BitCoin for trading 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