De hechtloze chirurgische technologie van de volgende generatie is gebaseerd op een klinisch bewezen platform en ontworpen voor duurzaamheid van de klep

LONDEN– (BUSINESS WIRE) – LivaNova PLC (NASDAQ: LIVN), een toonaangevend bedrijf op het gebied van medische technologie en innovatie, heeft vandaag aangekondigd dat de geavanceerde Perceval® Plus hechtloze chirurgische aortahartklep nu beschikbaar is voor commerciële introductie in Europa, met succes een een jaar beperkte lancering met initiële real-world klinische gegevensverzameling. Perceval Plus is gepositioneerd om een essentieel onderdeel te worden van elk uitgebreid hartprogramma. Voortbouwend op de klinisch bewezen ervaring met Perceval®, vergemakkelijkt deze volgende-generatie klep minimaal invasieve hartchirurgie (MICS) en maakt vervanging van de aortaklep zonder hechtingen beschikbaar voor een brede patiëntenpopulatie. Belangrijke innovaties met Perceval Plus zijn onder meer de GRATIS antikalkingsbehandeling voor klepduurzaamheid en ontwerpwijzigingen die de resultaten van de patiënt moeten verbeteren.

LivaNova Announces Commercial Launch of Perceval Plus Aortic Heart Valve in Europe

The next-generation sutureless surgical technology is based on a clinically proven platform and designed for valve durability

LONDON–(BUSINESS WIRE)– LivaNova PLC (NASDAQ:LIVN) a market-leading medical technology and innovation company, today announced that the advanced Perceval^® Plus sutureless surgical aortic heart valve is now available for commercial release in Europe, having successfully completed a one-year limited launch with initial real-world clinical data gathering. Perceval Plus is positioned to become an essential component to any comprehensive heart program. Building on the clinically proven experience with Perceval^®, this next-generation valve facilitates minimally invasive cardiac surgery (MICS) and makes sutureless aortic valve replacement available to a wide patient population. Key innovations with Perceval Plus include the anticalcification treatment, FREE, for valve durability, along with design changes intended to improve patient outcomes.

“Continual innovation for tissue heart valves is important for two primary reasons. First, our patients have a longer life expectancy, so we have to provide them with valves that have solid long-term performance. Second, we are using tissue valves more and more frequently in relatively younger patients,” said Prof. Bart Meuris, Head of Clinic of the University Hospital in Leuven, Belgium. “We have very good long-term clinical experience with the current Perceval platform,¹ and we expect Perceval Plus to deliver even better long-term outcomes with the FREE anticalcification treatment.”

Perceval Plus is the next generation of Perceval, which is a trusted technology with 13 years of clinical use and more than 50,000 implants worldwide. Key benefits of Perceval Plus are:

• Designed for durability: The unique FREE anticalcification tissue treatment combines phospholipid reduction and aldehyde neutralization with aldehyde-free storage.²
• Availability to a wide patient population: This valve is a versatile solution that can be used in complex or concomitant procedures and as a foundation for potential future Valve-in-Valve procedures.
• Facilitation of minimally invasive surgery: The truly sutureless surgical solution gives surgeons better visibility of the annulus and the anatomical structures.
• Designed to reduce permanent pacemaker implant (PPI) rates: Design enhancements, coupled with more efficient valve sizing, have been introduced with the goal of reducing pacemaker use.

“We are already seeing very promising initial results with Perceval Plus, contributing to the strong body of evidence for Perceval,” said Prof. Jens Wippermann, Clinical Director of the Cardio-thoracic surgery department at University of Magdeburg in Germany. “PPI has also been found to be substantially reduced with modified intraoperative approaches and an emphasis on proper valve sizing.”^1,2

The first Perceval Plus implant was performed in 2018 by Prof. Hermann Reichenspurner and Prof. Evaldas Girdauskas of the Department of Cardiothoracic Surgery at University Heart Center, Hamburg, Germany. After a limited commercial release in selected European centers and having secured two-year shelf life approval, Perceval Plus is now broadly available in CE Mark-dependent geographies.

“Through the innovations introduced with Perceval Plus and building upon the positive outcomes from the recent PERSIST-AVR clinical study, we are proud to deliver our next-generation sutureless surgical innovation to heart teams throughout Europe with the overall goal of improving patient outcomes,” said Stephanie Bolton, LivaNova President, Europe.

For more information on Perceval Plus, visit the LivaNova website.

About LivaNova

LivaNova PLC is a global medical technology and innovation company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in London, LivaNova employs approximately 4,000 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide. 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

This news release contains “forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding Perceval and Perceval Plus. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, as supplemented by any risk factors contained in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. We undertake no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

References

1. Szecel D, Meuris B. Long-term outcome with sutureless valves: 12 years of Perceval experience. Ann Cardiothorac Surg 2020. doi: 10.21037/acs.2020.04.03
2. Meuris B, De Praetere H, Strasly M, Trabucco P, Lai J, Verbrugghe P, et al. A novel tissue treatment to reduce mineralization of bovine pericardial heart valves. J Thorac Cardiovasc Surg. 2018;156(1):197-206. doi:10.1016/j.jtcvs.2018.01.099.

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Contacts

Deanna Wilke, +1 (281) 727-2764

VP, Corporate Communications

Corporate.Communications@livanova.com