Vivasure’s PerQseal Elite Closure Device Study Enrolls First Patients

December 12, 2023—Vivasure Medical announced enrollment of the first patients in its ELITE clinical study of the PerQseal Elite, which is the latest generation of the company’s fully absorbable percutaneous large-hole vessel closure system.

The prospective multicenter single-arm clinical study is evaluating the safety and efficacy of PerQseal Elite. The ELITE study will enroll up to 120 patients at up to 12 European investigational sites. Completion of the study is expected in 2024.

The first implantations were performed by ELITE principal investigator Professor Nicolas Van Mieghem, MD, at Erasmus University Hospital in Rotterdam, The Netherlands.

“Fast and precise vessel closure is a crucial, final component of large-bore arterial access procedures,” commented Prof. Van Mieghem in Vivasure’s press release. “Clinicians must act quickly to mitigate the risks of unnecessary and potentially life-threatening bleeding. The new anchoring system in the PerQseal Elite system holds immense promise for helping with acute performance, and I look forward to continuing the work to evaluate its performance for patients.”

According to the company, the PerQseal Elite system was designed to allow for faster delivery, improved performance in calcium, and treatment of large-hole venous procedures, such as transcatheter mitral valve repair and replacement. It is a sutureless, fully absorbable synthetic implant for large-bore vessel punctures. The company stated that the device is placed from inside the vessel, making deployment simpler and more controlled than conventional closure techniques.

In the United States, the company continues to enroll patients for its investigational device exemption clinical study for PerQseal and PerQseal+. The PerQseal device is not available for sale in the United States, advised Vivasure Medical.