Key findings from study at Leuven University Hospital show no
explants due to structural valve deterioration in 11 years of Perceval
LONDON–(BUSINESS WIRE)–lt;a href=”https://twitter.com/search?q=%24LIVN&src=ctag” target=”_blank”gt;$LIVNlt;/agt;–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)
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
The majority of the cases treated were all-comers, including
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
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
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
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.),
For more information, please visit www.livanova.com.
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LivaNova PLC Media Contact
Deanna Wilke, +1 (281)
Director, Corporate Communications