Business Wire

LIVANOVA-PLC

20.11.2019 12:02:04 CET | Business Wire | Press release

Share
LivaNova to Restructure its Heart Valve Business Line and End Caisson Transcatheter Mitral Valve Replacement Program

LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced it is ending its Caisson Transcatheter Mitral Valve Replacement (TMVR) program and will undertake a restructuring of its heart valve business to improve profitability and ensure business continuity.

“The time has come to address the continued declines we have experienced in our heart valve business. We will restructure and simplify our heart valve manufacturing network, which will eliminate operational overlap between facilities and enable us to address new regulatory requirements,” said Damien McDonald, Chief Executive Officer of LivaNova. “As we evaluated these changes along with those in the structural heart market, we determined it was no longer viable to continue to invest in our TMVR program. As a result, we will close our Caisson TMVR operations.”

The LivaNova heart valve business line represented nearly $130 million in revenue for full-year 2018 and has experienced a revenue decline over the last five years across both biological and mechanical valves. These declines were due to multiple market conditions, while portfolio maintenance costs increased specifically due to higher regulatory requirements. After a comprehensive analysis, the Company determined a restructuring is necessary.

Under this plan, LivaNova’s Saluggia, Italy facility will become dedicated to R&D and production of mechanical heart valves, rings, accessories and Nitinol stents. LivaNova tissue heart valve production will be concentrated in the Company’s Vancouver, Canada plant.

The closure of Caisson TMVR operations in Minneapolis, Minn. will be effective at the end of 2019. Patients who participated in clinical trials related to TMVR will continue to be followed within the parameters of the trial.

Under the restructuring plan, which will be implemented subject to any prior information and consultation procedure with social parties according to local legislation, it is expected that approximately 150 employees can be potentially impacted in the three sites of Saluggia, Vancouver and Minneapolis.

About LivaNova

LivaNova PLC is a global medical technology and innovation company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in London, LivaNova employs approximately 4,000 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide. LivaNova operates as two businesses: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), 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. You should carefully consider the risks and uncertainties that affect LivaNova, including those described in the “Risk Factors” section of LivaNova’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from time to time with the United States Securities and Exchange Commission.

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.

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Horizon3 Earns Cyber Essentials Certification Covering NodeZero EU Network28.9.2026 10:00:00 CEST | Press release

Certification provides a defined security baseline for the network supporting Horizon3’s EU data sovereignty site in Germany Horizon3, the AI-Native Proactive Security Company, today announced that it has earned Cyber Essentials Plus certification covering its NodeZero AWS EU network. The network supports Horizon3’s EU data sovereignty site in Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928143792/en/ Horizon3 Earns Cyber Essentials Certification Covering NodeZero EU Network Organizations use NodeZero® to test production environments and find weaknesses attackers can exploit. When customers and partners assess the platform itself, they also need to understand the security standards applied to its supporting infrastructure. The Cyber Essentials certificate identifies a defined portion of that infrastructure and the baseline against which it was assessed. Developed by the UK’s National Cyber Security Centre, Cybe

Thales Expands Collaboration with Google Cloud to Help Secure Agentic AI Workflows28.9.2026 09:03:00 CEST | Press release

Integration enables new protections for communications between AI agents, models, enterprise data, and tools to help control what agents can access, share, and do Thales AI Security Fabric mitigates risks, brings enhanced visibility and policy enforcement to AI-driven workflows on Google Cloud Thales today announced an expanded collaboration with Google Cloud to help enterprises address emerging security and governance challenges associated with agentic AI, bringing integrated protection, visibility, and policy enforcement to AI-driven workflows on Google Cloud. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928647188/en/ ©Thales The integration of Thales AI Security Fabric with Google Cloud Gemini Enterprise helps organizations apply security, governance, and visibility across interactions among users, agents, models, and tools in real time. “Enterprises are moving from AI assistants to AI agents that can autonomously ta

SPORVIGILANCE Targets Safer Medicines and Billion-Euro Savings for Global Pharma Facing EU IDMP Fines28.9.2026 08:13:00 CEST | Press release

British regulatory technology company SPORVIGILANCE is targeting one of global pharma’s major compliance challenges with a platform offering a faster route to IDMP and SPOR readiness, compliance and governance. As the European Medicines Agency advances structured medicinal product data, companies face pressure to keep regulatory data accurate, standardised and aligned with EMA requirements. SPORVIGILANCE replaces fragmented manual assessment with a regulatory intelligence layer built around IDMP, SPOR and Product Management Service (PMS) requirements. At its core is an IDMP Business Rule Validation Engine that assesses medicinal product data at scale and at field level, identifying missing, inconsistent and non-compliant data. SPORVIGILANCE is the only platform to translate IDMP business rules directly into automated validation logic, enabling companies to test data against the rules rather than rely on manual interpretation. Its PMS Alignment capability reconciles internal RIM data ag

Sofinnova Partners Closes Oversubscribed €82 Million Sofinnova MD Start IV Fund to Create the Next Generation of Medtech Companies28.9.2026 08:00:00 CEST | Press release

The new fund extends Sofinnova’s 20-year track record of company creation with capacity to launch six to eight new ventures across Europe and the US Sofinnova Partners ("Sofinnova"), a leading European life sciences venture capital firm based in Paris, London, and Milan, today announced the final close of Sofinnova MD Start IV at €82 million. The fund, which was oversubscribed, will help expand Sofinnova's medtech company-creation strategy across Europe and the US with greater capacity to launch new ventures and support them through key stages of development. With plans to launch six to eight new medtech companies over the next five years, Sofinnova MD Start IV will support ventures from inception through key clinical and operational milestones, providing founders with both capital and hands-on support. Sofinnova MD Start's approach combines clinical insight, entrepreneurial talent, and operational expertise to tackle significant unmet medical needs. The previous fund, Sofinnova MD Sta

Ant International’s Antom Upgrades Southeast Asia Leadership Structure to Drive Regional Synergy in the AI Era28.9.2026 07:18:00 CEST | Press release

Antom, a leading merchant payment and digitisation services provider under Ant International, today announced a series of key appointments for its operations in Southeast Asia to further strengthen the synergy among its regional brands and better serve regional merchants with streamlined full-stack AI-native solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260927431282/en/ Nabilah Alsagoff, co-founder and former chief operating officer of DOKU, Indonesia's leading payment fintech company, has been appointed as Head of Product, Antom SEA. In her new role, the payment veteran will oversee product development and innovation and drive a unified product roadmap for the overall SEA region. Chris Yeo, former chief executive officer (CEO) of DOKU, will take on the role as Head of Antom Philippines, and Country Head of 2C2P Philippines. With his long experience at DOKU, Grab and PayPal, Chris will also oversee the execution

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye