LivaNova PLC, a medical technology and innovation company, announced that the advanced Perceval Plus sutureless surgical aortic heart valve is now available 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.
 
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.