by The Irish company Vivasure Medical has submitted an application for the approval of the premarket (PMA) of the US Food and Drug Administration (FDA) for its Perqseal Elite Vascular closing system intended for arterial procedures.
This entry is supported by the results of the patch study and the clinical use of the system in Europe.
The company has also obtained the approval of CE marking for the extensive indication of Perqseal Elite in Europe, which now covers a venous closure of large drilling.
This follows the CE Mark inspection that the company received for the system in April, and offers a new bioresorbeable option for percutaneous vessel closure.
With the help of the Perqseal technology from Vivasure, the system is a completely absorbable, Sutureless closing device for use after percutaneous cardiovascular procedures.
Moreover, it claims to simplify the closing process because it does not require pre-procedure steps.
According to the company, the implementation of the system is from the ship and offers a simpler and controlled process compared to traditional closing methods.
It also ensures that the ship returns to its natural condition without leaving the collagen, metal implants or stitches.
The company received a strategic investment of € 30 million (around $ 34 million) from Haemonetics Corporation in 2023.
This agreement included an option for Haemonetics to acquire Vivasure Medical when reaching certain milestones.
Vivasure Medical CEO Andrew Glass said: “We are proud to promote Perqseal Elite via these two important milestones for regulatory authorities as part of our dedication to delivering the next generation technologies for vascular closure with large bore.
“Reaching CE expansion for venous indications and submitting our PMA application are important steps to make our fully absorbable, Sutureless solution more accessible, while continuing to lay a strong foundation for global commercial growth.”
In April 2024, the company dealt with the first venous subject in a trial with its Perqseal Elite Vascular closing system for closing with large bore.
“Vivasure submits PMA for vascular closing system at FDA” was originally made and published by Medical Device Network, a brand global data.
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