Perceval Sutureless Aortic Heart Valve Received Approval in China to Treat Patients with Aortic Valve Disease
LONDON--(BUSINESS WIRE)--CORCYM, the medical device company dedicated to providing patients and cardiac surgeons with the best solutions to fight structural heart disease, announces today the first Perceval implant in China, after the recent approval from the NMPA - National Medical Products Administration.
Perceval is a biological aortic valve with a sutureless and collapsible design that simplifies the surgical implantation, reducing the impact of surgery and facilitating faster patient recovery.1,2
“We at Fuwai Hospital implanted the first patient in China, a 61 years-old male, with a mini-sternotomy approach. Perceval provides cardiac surgeons with a new option to treat aortic valve disease. Thanks to its unique design, Perceval is an optimal technology to facilitate both surgeons even in complex cases and patients with a faster recovery. I’m sure that many other Chinese patients will benefit from it in the future” commented Dr. Shengshou Hu, Academician of Chinese Academy of Engineering, currently director of National Center for Cardiovascular Diseases and President of Fuwai Hospital.
Perceval has demonstrated excellent outcomes in clinical use in more than 75,000 patients implanted worldwide with 13 years of successful clinical results.3 Its safety and effectiveness in the Chinese population have been demonstrated by PERFECT (Perceval S Valve Clinical Study for Chinese Registration), the first pre-market, prospective, single-arm trial study enrolling Chinese patients implanted with a surgical sutureless valve.
“Perceval is the only sutureless valve now present in China. Its availability provides Chinese cardiac surgeons and patients with a new advanced solution, based on a robust body of evidence coming from its wide use in other Countries worldwide and from the outcomes of the PERFECT study.” Commented Jason Zhang, Country Manager Greater China at CORCYM.
“We at CORCYM are committed to help cardiac surgeons to treat their patients better today and in the future, worldwide. We are pleased to bring our unique sutureless valve as a treatment option available to patients in China”, added Christian Mazzi, CORCYM CEO.
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CORCYM is a global medical device company entirely focused on state-of-the-art surgical solutions to fight structural heart disease. CORCYM has a presence in more than 100 countries with approximately 850 employees and ensures strong continuous support to patients, healthcare professionals and healthcare systems worldwide. For more information, please visit www.corcym.com
1) Santarpino et al., "Sutureless aortic valve replacement: first-year single-center experience", Ann Thorac Surg. 2012 Aug;94(2):504-8.
2) Glauber M. et al., "International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches.", Innovations (Phila). 2016 May-Jun;11(3):165-73.
3) M. Lamberigts Abstract presented at EACTS 2021.
For media information:
Marina Curci, CORCYM Corporate Communication