New Data Emphasizing LivaNova Perceval Valve Durability to be Presented at the American Association for Thoracic Surgery Meeting
Key findings from study at Leuven University Hospital show no explants due to structural valve deterioration in 11 years of Perceval use
LONDON--(BUSINESS WIRE)-- LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced that new clinical data for its sutureless surgical aortic valve, Perceval®, will be unveiled at this year’s American Association for Thoracic Surgery (AATS) meeting.
On May 4, Prof. Bart Meuris from Leuven University Hospital (BE) will present the data from his center’s 11-year clinical experience with Perceval, which represents the longest clinical follow-up for the valve that has been published. The results demonstrate the strong performance of the Perceval valve both in terms of durability and outcomes, which reaffirm its position as a trusted platform. Of particular significance in the findings is the absence of explants due to structural valve deterioration (SVD), as well as the low rate of paravalvular leak (PVL) reported.
The retrospective, observational, single-center study included 468 consecutive patients implanted with Perceval between 2007 and 2017:
- Patient mean age was 79, mean EuroSCORE II was 5.0 and STS score was 5.8.
- The majority of the cases treated were all-comers, including emergencies.
- 55% of cases were conducted as part of concomitant procedures, while a high rate of the isolated aortic valve replacement (AVR) cases was carried out through minimally invasive surgery.
This new clinical data folds into the extensive literary evidence already available surrounding the Perceval technology and its use in hospitals around the world.
“The Perceval sutureless valve offers a stable, time-saving and safe surgical result, both in isolated and in combined procedures,” said Prof. Meuris based on the results from his 11-year experience with Perceval. “We observed promising long-term durability given the current low incidence of SVD after 11 years of continued clinical use.”
“It is critical for a distinctive technology such as Perceval to have strong, real life data to back up its success,” said Alistair Simpson, LivaNova General Manager of Cardiac Surgery. “We are extremely proud of these impressive results at Leuven that further demonstrate the versatility of our valve in isolated and concomitant procedures. The fact that no explants were carried out as a result of SVD, and that PVL was very low is a testament to the quality of our innovative valve design and to our commitment of improving patient care.”
The presentation by Prof. Meuris, “Sutureless AVR Experience in a Single Centre: 11 Years of Use in 468 Patients,” will take place on May 4 at AATS 2019 in Toronto:
- Session Name: Minimal Surgery and Novel Approaches
- Session Time: 10 - 11:30 a.m.
- Session Location: MTCC, 206AC
- Presentation Time: 11 - 11:15 a.m.
To read the abstract from the presentation, visit the AATS website.
For more information on the Perceval valve, visit www.livanova.com.
Important Safety Information
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.
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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LivaNova PLC Media Contact
Deanna Wilke, +1 (281) 727-2764
Director, Corporate Communications
Source: LivaNova PLC