LIVN LivaNova Plc

LivaNova Announces Publication of Literature Review Highlighting the Clinical Value and Safety of the Perceval Sutureless Valve for Aortic Valve Replacement

LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced the publication of the analysis, “The Perceval® Sutureless Aortic Valve: Review of Outcomes, Complications and Future Direction,” by Powell, Pelletier, Chu, Bouchard, Melvin and Adams in the latest issue of Innovations1. The literature review, which included a meta-analysis of 89 studies, highlighted Perceval as a safe aortic valve replacement option that provides a shorter procedure and recovery time along with favorable hemodynamics for patients.

The results of this literature review and meta-analysis demonstrated a statistically significant reduction in aortic cross-clamp and cardiopulmonary bypass times with Perceval when compared to stented biological aortic valves. Perceval provided safe clinical and hemodynamic outcomes, and showed a statistically significant reduction in paravalvular leakage and early mortality. Further, the survival rate was statistically significantly higher for Perceval in two studies when compared to transcatheter aortic valve implantation. An analysis of 17 single-arm studies showed that the 30-day mortality rate ranged from 0% to 4.9%, while the five-year survival rate ranged from 71.31% to 85.5% with Perceval1.

“With its distinctive design, the Perceval sutureless valve benefits cardiac surgeons performing aortic valve replacements underscored by the valve’s excellent durability and hemodynamic performance,” said Corey Adams, M.D., lead author of the analysis, from the Health Science Center, St. John’s, Canada.

As a truly sutureless aortic valve, Perceval has been shown to improve patient outcomes by providing reduced procedure time, minimizing postoperative complications, enabling shorter hospital stays and reducing the overall cost compared to traditional sutured valves2. Engineered to restore natural valve performance, the Perceval valve features a super-elastic stent, which is able to adapt to the movement of the aorta during the cardiac cycle. Including the period of clinical studies, the Perceval sutureless valve has been in use for a decade and has been implanted in more than 25,000 patients.

“Committed to developing state-of-the-art cardiac surgery solutions, we are proud to announce the publication of this comprehensive analysis that reinforces the growing body of literature highlighting the clinical value of the Perceval valve for surgeons and aortic valve replacement patients,” said Brian Duncan, M.D., Vice President, Medical Affairs, Cardiac Surgery at LivaNova. “With a decade of clinical use, the Perceval valve has been shown to produce safe and excellent hemodynamic outcomes for aortic valve replacement patients. We look forward to continuing to advance cardiac surgery solutions for patients everywhere.”

Learn more about Perceval and its patient benefits at www.heartvalvesurgery.com/sutureless.

1 Powell R, Pelletier MP, Chu MWA, Bouchard D, Melvin KN, Adams C. Innovations 2017 May/Jun;12(3):155-173.

2 Pollari F, et al. Ann Thorac Surg. 2014;98:611-6.

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

Any forward-looking statements are subject to risks and uncertainties such as those described in LivaNova’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

EN
11/09/2017

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