Vivasure Medical Secures CE Mark for First Fully Absorbable Large-Bore Vascular Closure System
核心洞察
Vivasure Medical (搜索) has received European CE mark approval for PerQseal Elite (搜索), the first fully absorbable, sutureless closure system designed specifically for large-bore cardiovascular procedures.
The innovative device aims to improve procedural efficiency and patient outcomes in structural heart interventions like TAVR (搜索) and EVAR (搜索), with planned launch in select European markets this summer.
Unlike current closure methods, PerQseal Elite (搜索) requires no pre-procedure steps and leaves no foreign materials behind, potentially reducing complications associated with traditional closure techniques.
Galway-based Vivasure Medical (搜索) announced today that it has received European CE mark approval for its PerQseal Elite (搜索) vascular closure system, the first sutureless and fully bioresorbable device designed specifically for large-bore vessel closure following complex cardiovascular procedures. The company plans to launch the product in select European markets this summer.
The PerQseal Elite (搜索) system represents a significant advancement in the management of vascular access sites following procedures such as transcatheter aortic valve replacement (搜索) (TAVR (搜索)) and Endovascular Aortic Repair (搜索) (EVAR (搜索)), which require large-bore access. Currently, no other fully bioresorbable devices are available for closure following these types of procedures.
Addressing an Unmet Clinical Need
Vascular closure remains a significant challenge in the growing field of structural heart interventions. The global arteriotomy closure device market was estimated at $1.8 billion in 2024 and is projected to reach $2.5 billion by 2034, according to analysis by GlobalData.
Dr. Mohamed Abdel-Wahab, Professor of Interventional Cardiology and Head of Structural Heart Disease Department at the Heart Center in Leipzig, Germany, highlighted the importance of this innovation: "Vascular closure remains a challenge for the growing cardiovascular procedures that require large bore access. The introduction of PerQseal Elite (搜索) is an exciting advancement for large-bore cardiovascular procedures."
He added, "Having a fully absorbable, sutureless closure option simplifies the procedure and has the potential to reduce complications associated with traditional closure methods. We look forward to utilizing this technology to treat our patients."
Innovative Design and Deployment
What sets the PerQseal Elite (搜索) system apart is its unique deployment mechanism and composition. The device is placed from inside the vessel, making deployment simpler and more controlled than conventional closure techniques. After placement, it returns the vessel to its natural state without leaving behind materials commonly used in other closure methods, such as collagen, metal implants, or sutures.
Unlike other current devices, PerQseal Elite (搜索) does not require any pre-procedure steps, which further simplifies the procedural workflow for clinicians.
Company Leadership and Investment
"Securing CE Mark approval for PerQseal Elite (搜索) marks a major milestone for Vivasure and for patients undergoing complex structural heart procedures," said Andrew Glass, CEO of Vivasure Medical (搜索). "PerQseal Elite represents a significant advancement in procedural efficiency and patient care. We're proud to bring this innovative technology to clinicians across Europe."
The Irish medical device company has secured substantial financial backing to support its innovations. In 2023, Vivasure received a €30 million strategic investment from Haemonetics Corporation, which includes an option to acquire Vivasure upon completion of certain milestones. The company is also supported by Fountain Healthcare Partners, Orchestra BioMed Holdings (搜索), LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners, and Evonik Venture Capital, as well as Enterprise Ireland and the European Investment Bank.
Market Availability
While the PerQseal Elite (搜索) system will soon be available in European markets, it is not yet approved for sale in the United States. The company operates a fully integrated R&D and ISO 13485 certified manufacturing facility in Galway, Ireland, focusing on the development of advanced polymer implants and delivery systems for minimally invasive vessel closure in cardiology, interventional radiology, and vascular surgery.
As the number of structural heart procedures continues to grow globally, innovations like the PerQseal Elite (搜索) system may play a crucial role in improving procedural outcomes and patient recovery following these increasingly common interventions.