Business Wire

LivaNova Bicarbon Aortic Valves Receive CE Mark for Expanded Use Labeling with Lower-Dose Blood Thinners in Low-Risk Patients

Del

LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, has received CE Mark approval for its Bicarbon ® aortic valves for use with low-dose anticoagulant therapy. The expanded CE labeling means that a lower international normalized ratio (INR), the standardized index used to measure blood coagulability, can be targeted following Bicarbon aortic valve implantation in low-risk1 patients undergoing single bileaflet mechanical aortic valve replacement.

“When choosing a mechanical valve, patients look for a treatment option which lasts for life. The lower INR range approval for LivaNova Bicarbon Aortic Valves means patients now have a greater choice when selecting a mechanical prosthesis, with the freedom to enjoy a more active, confident lifestyle,” said Alistair Simpson, General Manager of LivaNova’s Cardiac Surgery business franchise.

Patients with mechanical heart valves are at risk of blood clot formation (thrombosis and embolism). These patients are placed on lifelong anticoagulant therapy, which can cause side effects, including an increased bleeding risk. After implanting LivaNova Bicarbon aortic heart valves in patients at low risk for thromboembolic events, physicians can now work with a lower-range level of anticoagulant therapy (INR range of 1.5 to 2.5 with 1.9 median target), potentially reducing the risk of bleeding with no increased risk of blood clots.

In more than 25 years of clinical use and up to 17 years of published follow-up2, the Bicarbon family of mechanical valves has shown evidence of a very low incidence of thrombogenicity.

The expanded indication for the Company’s Bicarbon family of aortic heart valves is based on this evidence and the results from the LOWERING-IT trial where patients saw a 60 percent reduction in risk of bleeding3.

“Our experience from the LOWERING-IT trial with nearly 300 patients implanted with Bicarbon aortic valves maintained with an INR close to 1.9, with a median follow-up of over five years was presented at the American Heart Association 2017 meeting in Anaheim, California,” said study lead author Michele Torella, M.D., Ph.D., Department of Cardio-Thoracic and Respiratory Sciences, Monaldi Hospital, Second University of Naples, Naples, Italy. “Our study indicated that the proposed low-INR range between 1.5 and 2.5 (with 1.9 median target) is safe and feasible in low-risk patients after isolated aortic valve replacement with LivaNova’s Bicarbon prosthesis, resulting in similar thrombotic events and in a significant reduction of bleeding occurrence when compared to the conventional anticoagulation regimen.”

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, LivaNova has a presence in more than 100 countries worldwide. The Company currently employs more than 4,500 employees, inclusive of approximately 900 employed by our CRM business franchise. 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

This news release contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe LivaNova’s future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," “could,” “seek,” “guidance,” “predict,” “potential,” “likely,” "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this news release are based on information presently available to LivaNova and assumptions that LivaNova believes to be reasonable, but are inherently uncertain. As a result, LivaNova’s actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance or actions that may be taken by LivaNova and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond LivaNova’s control.

All information in this news release is as of the date of its release. LivaNova does not undertake or assume any obligation to update publicly any of the forward-looking statements in this news release to reflect actual results, 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 news release.

1. INR range 1.5-2.5 in patients at low risk for thromboembolic events undergoing single mechanical aortic valve replacement
2. Single center experience with the Sorin Bicarbon prosthesis: A 17-year clinical follow-up. Celiento et al. - J Thorac Cardiovasc Surg 2014;148:2039-44
3. LOWERing the intensity of oral anticoagulant Therapy in patients with bileaflet mechanical aortic valve replacement: Results from the “LOWERING-IT” Trial. Torella et al. - Am Heart J 2010;160:171-8

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

(c) 2018 Business Wire, Inc., All rights reserved.

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

Cloudreach Gets Closer to its Nordic Customers With Presence in Stockholm, Sweden19.3.2019 08:00:00 CETPressemelding

Cloudreach, a global, cloud-native solutions provider, has announced today that it will be establishing a new base in Stockholm, Sweden. The new location will enable customers in the Nordic region to accelerate their transformation journey with enhanced service and support from Cloudreach locally. The Nordics are rapidly becoming a key market for Cloudreach, and the company already has high-profile clients in the region. Home to many well-known brands and global corporations, the Nordics have also shown a particular appetite for cloud computing services in recent years, with Finland, Sweden and Denmark leading the way in cloud adoption. The opportunities in the cloud market have been noticed by the major Cloud Service Providers, with AWS, Azure and GCP choosing Sweden, Norway and Finland respectively, as the locations for their data centres in the region. “I'm delighted to confirm Cloudreach's commitment to supporting both existing and new customers, locally with our expansion into the

Mobidiag to Attend the 29th European Congress of Clinical Microbiology & Infectious Diseases in Amsterdam, the Netherlands19.3.2019 07:00:00 CETPressemelding

Mobidiag Ltd., a commercial stage molecular diagnostics company addressing the spread of antimicrobial resistance, will be attending the 29th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Amsterdam, the Netherlands, from 13-16 April 2019. Organised by Europe’s leading society in clinical microbiology and infectious diseases, the ECCMID annual meeting brings together leading experts from around the world, including innovative commercial companies specializing in diagnostics. Mobidiag will be hosting an Exhibit Booth (#1.62, Hall 3) at ECCMID. The Company will demonstrate its proprietary diagnostic solutions, Amplidiag® and Novodiag® and showcase how these can be used to provide fast, accurate and accessible solutions for the diagnosis of infectious diseases and, particularly in antimicrobial resistance. Mobidiag has made significant progress in recent months, including: Mobidiag Joint Venture with Autobio Diagnostics and €10m equity investment (17/12/18) M

Western Union Teams Up with Thunes to Expand Payout Capabilities to Mobile Wallets19.3.2019 01:00:00 CETPressemelding

Western Union (NYSE: WU), a leader in cross-border, cross-currency money movement, has teamed up with Thunes, a cross-border payments network for emerging markets, to enable Western Union customers to send funds directly into mobile wallets around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005639/en/ Senders can now utilise Western Union’s growing digital network or an agent location to send funds directly into a recipient’s mobile wallet. “We are continuously expanding and enhancing our account payout portfolio, providing customers with multiple payout options including bank accounts, cards or mobile wallets,” said Sobia Rahman, Global Head of Account Payout Network for Western Union. “Our goal is to make digital money transfer services more accessible, with a specific focus on enabling mobile transactions.” The collaboration will enable greater financial access for consumers - especially those who lack

Velodyne Demonstrates Lidar Solution for Rich Perception Data Collection on NVIDIA DRIVE Platform19.3.2019 01:00:00 CETPressemelding

Velodyne Lidar, Inc. today announced its surround-view lidar solutions for collecting rich perception data in testing and validation are available on the NVIDIA DRIVE™ autonomous driving platform--allowing full, 360-degree perception in real time, facilitating highly accurate localization and path-planning capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005791/en/ Proven through learning from millions of road miles, Velodyne sensors help determine the safest way to navigate and direct a self-driving vehicle. (Photo: Business Wire) Velodyne sensors’ characteristics are also available on NVIDIA DRIVE Constellation™, an open, scalable simulation platform that enables large-scale, bit-accurate hardware-in-the-loop testing of AVs. The solution’s DRIVE Sim™ software simulates lidar and other sensors, recreating a self-driving car’s inputs with high fidelity in the virtual world. “Velodyne and NVIDIA are at the f

Kohler Celebrates the Details of Design at Milan Design Week 201919.3.2019 00:22:00 CETPressemelding

Kohler, a global lifestyle brand, returns to Milan Design Week to host an enticing sensory experience inside the historic Palazzo Del Senato (via Senato, 10, 20121 Milan, Italy). The large-scale immersive exhibit showcases Kohler’s bold approach to design and the brand’s most stunning products through an artful combination of water, technology, texture, and color. The installation will be open April 9 through April 13 from 10am – 7pm daily. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005858/en/ The large-scale immersive exhibit showcases Kohler’s bold approach to design and the brand’s most stunning products through an artful combination of water, technology, texture, and color. The installations feature global debuts of products from KOHLER, KALLISTA, ANN SACKS and ROBERN. (Photo: Business Wire) “Milan Design Week is the ultimate celebration of creativity and innovation among the global design community,” said Jim

ams and Wise Road Capital Advance Further Development for Environmental, Flow and Pressure Sensors Through Creation of a Joint Venture19.3.2019 00:09:00 CETPressemelding

ams (SIX: AMS), a leading worldwide supplier of high performance sensor solutions, and Wise Road Capital, a global Private Equity firm focusing on the semiconductor industry and other emerging high-tech industries, announce today that they have signed an agreement to create a joint venture to advance the development and sales of environmental, flow and pressure sensor solutions for the global market. Under the agreement, employees, IP, sensor products and solutions and related customers will transfer from ams to the joint venture, while Wise Road Capital will provide its expert joint venture guidance, deep market knowledge and strength in channel and customer relationships, especially in China. ams will transfer its current environmental sensor solution portfolio covering air quality, relative humidity and temperature sensing, which are used in automotive, smart building and air quality monitoring infrastructure applications. In addition, the ams ultrasound-based flow sensor solutions,