LivaNova Receives U.S. FDA 510(k) Clearance for LifeSPARC Advanced Circulatory Support System

The versatile and compact system offers the power and simplicity to support more patients in more places

LONDON--()--LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Advanced Circulatory Support (ACS) pump and controller, the LifeSPARC system. Derived from more than 20 years of life support experience with TandemLife, LifeSPARC begins a new chapter for ACS innovation within the LivaNova portfolio.

Built around a common compact console and pump, LifeSPARC provides temporary support for emergent rescue patients in a variety of settings. Designed for ease of use, the system offers more power and versatility for multi-disciplinary programs to support more patients. The system is accompanied by four specialized and ready-to-deploy kits, each designed to support diverse cannulation strategies.

“LifeSPARC is the new generation pump and controller for the venerable Tandem system – a small but powerful heart pump with a magnetic bearing, a low-profile controller and a highly simplified user interface. I believe many more patients will have access to this higher level of support for the first time,” said Dr. David Baran, System Director for Advanced Heart Failure Transplant and Mechanical Circulatory Support at Sentara Heart Hospital in Norfolk, Va. “In particular, small- and mid-sized hospitals, which have historically had limited access to this type of technology, may now be able to provide this potentially life-saving therapy to critically ill cardiac and respiratory failure patients in need of Advanced Circulatory Support. The overall versatility of the LifeSPARC system may help to propel Mechanical Circulatory Support programs forward.”

“We are delighted to announce the upcoming availability of our new LifeSPARC system, and we believe this will become an essential asset in the hands of healthcare professionals,” said Damien McDonald, Chief Executive Officer of LivaNova. “Millions of patients are affected by cardiac and respiratory disease each year, and LifeSPARC was designed to ensure more of these patients can be supported with a single system that is simple enough for new practitioners and powerful enough for expert-level hospital centers.”

LivaNova expects to commence the limited commercial release of LifeSPARC in the United States later this year, with full commercial release expected by the end of 2019. Availability in other countries is anticipated to begin in 2020.

In the U.S., the LifeSPARC system is intended to pump blood through an extracorporeal circuit for periods lasting less than six hours for the purpose of providing either: (i) full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

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 approximately 4,000 employees. 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.

Contacts

LivaNova PLC Media Contact
Deanna Wilke, +1 (281) 727-2764

Director, Corporate Communications
Corporate.Communications@livanova.com

Release Summary

LivaNova announced it received 510(k) clearance from the FDA for its new Advanced Circulatory Support pump and controller, the LifeSPARC system.

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Contacts

LivaNova PLC Media Contact
Deanna Wilke, +1 (281) 727-2764

Director, Corporate Communications
Corporate.Communications@livanova.com