New LivaNova heart valve available for European release
LivaNova’s 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.
Building on the clinically proven experience with Perceval, this 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.
Prof. Bart Meuris, head of clinic of the University Hospital in Leuven, Belgium, said: “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. We have very good long-term clinical experience with the current Perceval platform, and we expect Perceval Plus to deliver even better long-term outcomes with the FREE anticalcification treatment.”
The product is:
- Designed for durability: The anticalcification tissue treatment combines phospholipid reduction and aldehyde neutralisation with aldehyde-free storage.
- Available to a wide patient population: This valve can be used in complex or concomitant procedures and as a foundation for potential future Valve-in-Valve procedures.
- 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.
Prof. Jens Wippermann, clinical director of the cardio-thoracic surgery department at University of Magdeburg in Germany, said: “We are already seeing very promising initial results with Perceval Plus, contributing to the strong body of evidence for Perceval. PPI has also been found to be substantially reduced with modified intraoperative approaches and an emphasis on proper valve sizing.”
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 Centre, Hamburg, Germany. After a limited commercial release in selected European centres and having secured two-year shelf life approval, Perceval Plus is now broadly available in CE mark-dependent geographies.
Stephanie Bolton, LivaNova president, Europe, said: “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.”