LivaNova announces the commercial launch of the Perceval Plus aortic valve in Europe

“Continuous innovation in the field of tissue heart valves is important for two main reasons. First, our patients have a longer life expectancy, which is why we need to provide them with valves that provide strong long-term performance. Second, we are using tissue valves more and more often in relatively younger patients, ”said Professor Bart Meuris, head of clinic at the University Hospital of Leuven in Belgium. “We are seeing very favorable long-term clinical experience with the current Perceval, ¹ platform and expect Perceval Plus to deliver even more favorable long-term results with the FREE calcification treatment.” “

Perceval Plus is the new generation of Perceval, which is a proven technology with 13 years of clinical use and more than 50,000 implants worldwide. Among the main advantages of Perceval Plus are:

• A design focused on durability: The unique and FREE tissue treatment against calcification combines a reduction of phospholipids and neutralization of aldehydes with aldehyde-free storage. ²
• Availability for a large patient population: This valve is a versatile solution that can be used in complex or concomitant interventions, and as a basis for future “Valve-in-Valve” interventions.
• Facilitation of minimally invasive surgery: This truly sutureless surgical solution gives surgeons better visibility on the annulus, as well as on anatomical structures.
• Designed to reduce implantation rates of permanent pacemakers (PPIs): Several design improvements, associated with more efficient valve dimensions, have been introduced with the goal of reducing the use of pacemakers.

“We are already seeing very promising initial results with Perceval Plus, which contribute to the strong body of evidence in favor of Perceval,” said Professor Jens Wippermann, clinical director of the University’s Cardiothoracic Surgery Department. from Magdeburg in Germany. “The PPI rate was also found to be significantly reduced thanks to the modification of intraoperative approaches, as well as an emphasis placed on an appropriate valve dimension. » ^1.2

La première implantation du Perceval Plus a été effectuée en 2018 par le professeur Hermann Reichenspurner et le professeur Evaldas Girdauskas du service de chirurgie cardio-thoracique du Centre universitaire de cardiologie de Hambourg en Allemagne. À l’issue d’un lancement commercial limité dans certains centres européens, ainsi que de l’obtention de l’autorisation d’une durée de validité de deux ans, Perceval Plus est désormais largement disponible dans les régions géographiques exigeant un marquage CE.

“Thanks to the innovations introduced in Perceval Plus, and building on the positive results of the recent PERSIST-AVR clinical study , we are proud to deliver our next generation suture-free surgical innovation to cardiology teams across Europe, with the overall goal of improving patient outcomes, ”said Stephanie Bolton, President of LivaNova in Europe.

To learn more about Perceval Plus, visit the LivaNova website .

About LivaNova

LivaNova PLC is a global medical technology and innovation company founded on nearly five decades of experience and a relentless commitment to bringing hope to patients and their families through innovative medical technologies and life-changing improvements, whether in the head or heart. Based in London, LivaNova employs approximately 4,000 people and is present in over 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide. LivaNova specializes in two activities: Cardiac surgery and neuromodulation, with operating offices in Mirandola (Italy) and Houston (United States), respectively.

For more information, visit www.livanova.com .

Safe Harbor Declaration

This press release contains “forward-looking statements” regarding our underlying goals, beliefs, expectations, strategies, objectives, plans and assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements relating to Perceval and Perceval Plus. Actual results could turn out to be significantly different from those expressed in our forward-looking statements due to various factors, including the factors set out in point 1A of our annual report on Form 10-K for the year ended December 31, 2019, as supplemented by any risk factor contained in our quarterly reports on Form 10-Q and our current reports on Form 8-K.We do not undertake to update the information contained in this press release to reflect subsequent 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 (An innovative tissue treatment aimed at reducing the mineralization of bovine pericardial valves). J Thorac Cardiovasc Surg. 2018; 156 (1): 197-206. doi: 10.1016 / j.jtcvs.2018.01.099.

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