- Vivasure Medical received CE Mark approval for its PerQseal Elite vascular closure system in Europe.
- PerQseal Elite is the first fully absorbable, sutureless closure system for large-bore procedures.
- The device is set to launch in select European markets in summer 2023.
Vivasure Medical, a company at the forefront of innovative vascular closure technology, has announced the receipt of CE Mark approval for its PerQseal® Elite vascular closure system in Europe. This device represents a significant advancement in the field of cardiovascular procedures, being the first fully absorbable and sutureless closure system specifically designed for large-bore procedures such as transcatheter aortic valve replacement (TAVR) and Endovascular Aortic Repair (EVAR).
The PerQseal Elite system offers a groundbreaking solution, eliminating the need for pre-procedure steps and leaving no permanent materials behind, thereby enhancing procedural efficiency and patient outcomes. Dr. Mohamed Abdel-Wahab, a renowned Professor of Interventional Cardiology, emphasizes its potential to simplify procedures and reduce complications compared to traditional closure methods.
Andrew Glass, CEO of Vivasure Medical, hailed the CE Mark approval as a pivotal milestone that will enhance the care of patients undergoing complex structural heart procedures across Europe. The product is anticipated to be available in select European markets in the summer of 2023, further expanding Vivasure’s reach in the medical field.
Vivasure Medical, headquartered in Galway, Ireland, specializes in advanced polymer implants and delivery systems. Supported by significant investments, including a €30 million injection from Haemonetics Corporation (HAE, Financial), the company is well-positioned to revolutionize vascular closure technology.
