Corcym has secured FDA approval for an enhanced version of its Perceval Plus surgical aortic heart valve, incorporating advanced LANCELOT features that promise improved procedural consistency and valve performance.
The newly approved device maintains the innovative sutureless, collapsible frame design of its predecessor while introducing two significant technological improvements. The updated valve features precision laser-cut leaflets and thread holes, engineered to enhance manufacturing consistency. Additionally, a novel zero-pressure fixation process has been implemented to minimize stress on the valve leaflets.
"For many years, Perceval has been well-known as the only sutureless valve designed to simplify surgical implantation, reducing the impact of surgery with faster patient recovery," stated Christian Mazzi, Corcym CEO. "We expect LANCELOT technologies to take it a step further, delivering the next generation of reproducibility and consistency in valve performance for cardiac surgeons and their patients around the world."
Technical Innovations and Clinical Impact
The Perceval Plus with LANCELOT technology is specifically designed for surgical aortic valve replacement (SAVR) procedures. Its sutureless design aims to streamline the implantation process, potentially reducing procedural complexity and supporting faster post-operative recovery for patients requiring aortic valve replacement.
Strategic Market Position
In an era where many medical device companies are shifting their focus toward transcatheter aortic valve replacement (TAVR) technologies, Corcym has maintained its dedication to advancing surgical solutions. This strategic position underscores the continuing importance of surgical approaches in cardiac valve replacement.
"We at Corcym are committed to helping cardiac surgeons excel and treat their patients better today and in the future, worldwide," Mazzi emphasized. "We are pleased to bring these new surgical aortic valve technologies as a treatment option to patients in the U.S."