Vivasure Medical has received CE mark certification in Europe for its PerQseal Elite vascular closure system, a development that enables the company to commence commercial rollout in select European countries this summer.
The device, which is sutureless and fully bioresorbable, is intended for large-bore vessel closure following cardiovascular interventions.
PerQseal Elite is built on Vivasure’s proprietary PerQseal technology and has been developed for use in procedures such as transcatheter aortic valve replacement (TAVR) and endovascular aortic repair (EVAR).
The system offers a percutaneous solution designed to close large-bore vessels without leaving permanent materials in the body. Its sutureless configuration eliminates the need for any preparatory steps prior to use, which aims to simplify procedural workflows compared to existing alternatives.
The product is said to be the only fully bioresorbable closure system currently available for use in large-bore cardiovascular procedures.
According to Vivasure, the design facilitates closure from within the vessel. It aims to restore the vessel to its original condition without reliance on components such as collagen plugs, metal implants, or sutures that are typically associated with other closure techniques.
Vivasure Medical CEO Andrew Glass said: “Securing CE Mark approval for PerQseal Elite marks a major milestone for Vivasure and for patients undergoing complex structural heart procedures.
“PerQseal Elite represents a significant advancement in procedural efficiency and patient care.”
With regulatory clearance in hand, Vivasure now intends to introduce the PerQseal Elite system in selected European markets over the coming months.
Vivasure Medical, headquartered in Galway, Ireland, specialises in the development of advanced polymer-based implants and delivery technologies. The firm primarily focuses on minimally invasive vessel closure solutions across cardiology, interventional radiology, and vascular surgery.
In 2023, the company secured a €30m investment from Haemonetics. Under an agreement signed by the parties, there is an option for Haemonetics to acquire Vivasure upon the achievement of specified milestones.
