LivaNova has 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.
The next-generation valve facilitates minimally invasive cardiac surgery (MICS) and makes sutureless aortic valve replacement available to a wide patient population, LivaNova said in a press release. 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 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.”
“We are already seeing very promising initial results with Perceval Plus, contributing to the strong body of evidence for Perceval,” said Jens Wippermann, Clinical Director of the Cardio-thoracic surgery department at University of Magdeburg, Germany. “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 Hermann Reichenspurner and Evaldas Girdauskas of the Department of Cardiothoracic Surgery at University Heart Center, 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.
“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.