Vivasure PerQseal Elite Approved for Venous Indication in Europe

June 24, 2025—Vivasure Medical announced that it has received European CE Mark approval for an expanded indication for its fully bioresorbable, sutureless PerQseal Elite vascular closure system to include large-bore venous closure.

Additionally, Vivasure announced the submission of a premarket approval application to the FDA for the PerQseal Elite for arterial procedures.

CE Mark approval of the PerQseal Elite device for arterial procedures and positions was announced in April 2025.

The company previously announced that PerQseal Elite, which now has CE Mark approval for both arterial and venous access closure, will be launched in select European markets in summer 2025.

Vivasure stated that the FDA submission builds on the results of the PATCH study (presented at TCT 2024) and positive clinical use in Europe, both reinforcing the system’s potential safety and performance profile.

Azeem Latib, MD, Section Head and Director of Interventional Cardiology and Director of Structural Heart Interventions at Montefiore Health System in New York, New York, commented on the PerQseal Elite device in the company’s press release.

“With the increasing adoption of minimally invasive therapies in structural heart and electrophysiology procedures, managing large-bore access sites remains a critical consideration,” stated Dr. Latib. “PerQseal Elite was designed to address the growing need with a novel, fully bioabsorbable approach, and we look forward to further progress in the program.”