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
The results from the Perceval Aortic Heart Valve Study in
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
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.
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.,
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.
“These three publications add to the already significant body of evidence available on Perceval,” said
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”,
3 Povero et al, “Cost-utility of surgical sutureless bioprostheses vs TAVI in aortic valve replacement for patients at intermediate and high surgical risk”,
Important Safety Information
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.
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 (
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
All information in this news release is as of the date of its release.
LivaNova PLC Media Contact
Deanna Wilke, +1 (281) 727-2764
Director, Corporate Communications