Irish company Vivasure Medical has submitted an application seeking premarket approval (PMA) from the US Food and Drug Administration (FDA) for its PerQseal Elite vascular closure system intended for arterial procedures.
This submission is supported by the outcomes of the PATCH study and the system’s clinical use in Europe.
The company has also secured CE mark approval for PerQseal Elite鈥檚 expanded indication in Europe, now covering large-bore venous closure.
This follows the CE mark approval received by the company in April for the system, providing a new bioresorbable option for percutaneous vessel closure.
Using Vivasure鈥檚 PerQseal technology, the system is a fully absorbable, sutureless closure device for use after percutaneous cardiovascular procedures.
Additionally, it claims to simplify the closure process as it does not require any pre-procedure steps.
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By GlobalDataAccording to the company, the system’s deployment is from inside the vessel, offering a simpler and controlled process compared to traditional closure methods.
It also ensures that the vessel returns to its natural state without leaving the collagen, metal implants, or sutures.
The company received a 鈧�30m strategic investment (approximately $34m) from Haemonetics Corporation in 2023.
This agreement included an option for Haemonetics to acquire Vivasure Medical upon the achievement of certain milestones.
Vivasure Medical CEO Andrew Glass said: 鈥淲e are proud to advance PerQseal Elite through these two key regulatory milestones as part of our commitment to delivering next-generation technologies for large-bore vascular closure.
鈥淎chieving CE mark expansion for venous indications and submitting our PMA application are important steps toward making our fully absorbable, sutureless solution more broadly accessible, while continuing to build a strong foundation for global commercial growth.鈥�
In April 2024, the company treated the first venous subject in a trial of its PerQseal Elite vascular closure system for large-bore vessel closure.
