New Studies in the U.S. and Europe Demonstrate LivaNova Perceval Valve's Strong Performance and Economic Advantage in Aortic Disease Treatment

Recently published data reinforces the ability of Perceval to optimize the surgical approach to aortic valve replacement

LivaNova PLC LIVN, a market-leading medical technology company, today announced the publication of three separate studies highlighting the unique performance of its sutureless aortic valve, Perceval^®.

The results from the Perceval Aortic Heart Valve Study in North America, performed under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE), were published in the Journal of Thoracic and Cardiovascular Surgery¹. The study confirmed that Perceval achieves positive safety and efficacy outcomes whether or not an open or minimally invasive surgical approach is used. The multi-center, prospective, non-randomized, single-arm clinical trial included 300 patients from 18 U.S. centers.

The primary endpoints of this landmark study included safety (mortality and morbidity) and effectiveness (clinical status, hemodynamic performance and quality of life) at one year and highlighted positive outcomes for Perceval, including:

• Substantial functional improvement with 97.6% of patients in New York Heart Association (NYHA) class I/II after surgery.
• Significant improvement in quality of life metrics.
• Overall low hospital mortality (1.3%) and rate of ≥ moderate paravalvular leak (1.3%).

In addition, two separate articles were recently published and serve as further proof of the favorable economic profile of the Perceval valve.

The second article² compares costs associated with the Perceval sutureless valve to those of traditional sutured valves. In the study at the Poliambulanza Hospital in Brescia, Italy, Perceval was assigned to patients at higher surgical risk, while a cohort of patients at lower surgical risk was treated with traditional sutured valves. Daily per patient costs were calculated and included preoperative tests, operating costs, disposables, drugs, blood components and personnel costs.

The results demonstrated that hospital costs excluding the prosthesis were similar in the two groups, despite the higher risk of complexity for the cases in the Perceval group. "Despite higher operative risks in the Perceval group, hospital mortality, morbidity and resource consumption did not differ," said Dr. Giovanni Troise, Head Cardiac Surgeon at Poliambulanza Hospital. "Operating times were shorter with the sutureless device. This improvement, coupled with the increasing adoption of minimally invasive approaches, should further favor the Perceval valve's market acceptance."

The third article³ assessed the incremental cost-utility of surgical sutureless aortic valves compared to transcatheter aortic valves, for the treatment of intermediate- to high-risk patients in the U.S., Germany, France, Italy, UK and Australia. The cost-utility study relied on a meta-analysis comparing efficacy and safety outcomes. The study analyzed more than 1,400 patients treated with either surgical sutureless valves (95% of which were Perceval patients) or transcatheter aortic valves. A simulation estimated the long-term consequences following patient discharge from hospital.

Due to lower in-hospital and overall mortality rates, the study showed that patients treated with Perceval are expected to live an average of 1.14 quality-adjusted life-years (QALYs) greater than those treated with a transcatheter aortic valve.

Lifetime cost savings were reported across the board in all geographies under analysis. "These relevant findings acknowledge the clinical and economic relevance of adding sutureless valves as an integral part of your Structural Heart program," said Dr. Mattia Glauber, Head Cardiac Surgeon at Istituto Clinico Sant'Ambrogio in Milan, Italy. "Our institution performs Perceval implantations on a routine basis via right anterior thoracotomy - the ultimate minimally invasive surgical procedure. This approach generates clear patient benefits, economic advantages and represents an ideal complement to transcatheter aortic valves in the appropriate patient risk category."

"These three publications add to the already significant body of evidence available on Perceval," said Alistair Simpson, LivaNova General Manager of Cardiac Surgery. "We are delighted to see the positive clinical results generated by Perceval, and to read that our unique valve is being recognized as a financially viable option for the treatment of aortic valve diseases. Achieving cost reductions while improving outcomes is of paramount importance to healthcare systems worldwide. We are proud to see that Perceval is helping realize both."

For more information on the Perceval valve, please visit www.livanova.com.

¹ Suri et al, "Prospective US Investigational Device Exemption Trial of a Sutureless Aortic Bioprosthesis: One-Year Outcomes", JTCVS 2018 – Article in press, DOI: https://doi.org/10.1016/j.jtcvs.2018.08.121

² Villa et al, "Sutureless aortic valve replacement in high risk patients neutralizes expected worse hospital outcome: A clinical and economic analysis", Cardiology Journal 2018 – Epub ahead of print+, DOI: 10.5603/CJ.a2018.0098 https://journals.viamedica.pl/cardiology_journal/article/view/CJ.a2018.0098

³ Povero et al, "Cost-utility of surgical sutureless bioprostheses vs TAVI in aortic valve replacement for patients at intermediate and high surgical risk", ClinicoEconomics and Outcomes Research 2018:10 733–745, DOI https://doi.org/10.2147/CEOR.S185743

Important Safety Information

INDICATIONS

EUROPE: The Perceval prosthesis is indicated for the replacement of diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The prosthesis is indicated for use in adult patients who are diagnosed to have aortic valve stenosis or steno-insufficiency.

USA: The Perceval bioprosthesis is indicated for the replacement of diseased, damaged or malfunctioning native or prosthetic aortic valves.

CANADA: The Perceval S bioprosthesis is intended for use in patients aged ≥ 65 years when the aortic valve pathology is in an advanced stage to require the replacement of the native or malfunctioning previously implanted prosthesis.

AUSTRALIA: Perceval S prosthesis is indicated for the replacement of a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The prosthesis is indicated in patients who meet the following criteria: 1) subjects of age ≥ 65 years 2) subjects with aortic valve stenosis or steno-insufficiency.

TOP POTENTIAL SIDE EFFECTS

The risks or potential adverse events associated with cardiac valve replacement with a bioprosthesis include, but may not be limited to: cardiac arrhythmias, death, endocarditis, heart failure, hemorrhage, intravalvular and/or paravalvular leak, stroke or any related neurologic disorders, structural valve deterioration, reoperation and explant. Beyond the previously mentioned adverse events, specific events related to the implant of the Perceval prosthesis may include, but not be limited to dislodgment and/or migration of the prosthesis. MRI conditional.

For professional use. Please contact us through our website to receive instructions for use containing full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Not approved in all geographies. Consult your labeling.

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

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