Vivasure Commences ELITE-Venous Study of PerQseal Elite Vascular Closure System  

April 15, 2024—Vivasure Medical announced it has treated the first large-bore venous patient with the PerQseal Elite vascular closure system. Vivasure is a Galway, Ireland–based company focused on fully absorbable technology for percutaneous vessel closure.

The first successful implantation was completed as part of Vivasure’s ELITE-Venous clinical study.

According to the company, ELITE-Venous is evaluating the safety and efficacy of the PerQseal Elite vascular closure system. The prospective, multicenter, single-arm study will enroll up to 97 patients at up to 12 sites in Europe. Completion of the study is expected this year, and results will support CE Mark and premarket approval submissions.

The procedure was performed by Professor Nicolas Van Mieghem, MD, Clinical Director of Interventional Cardiology at the Thoraxcentre, Erasmus Medical Centre in Rotterdam, the Netherlands, and Principal Investigator of the ELITE study.

Vivasure stated that the PerQseal Elite vascular closure system is designed exclusively for sutureless and fully bioresorbable large-bore venous vessel closure after percutaneous cardiovascular procedures, such as transcatheter mitral valve repair or replacement (TMVR), transcatheter tricuspid valve repair or replacement (TTVR), and leadless pacemaker implants.

“Current venous closure methods are not indicated for large-hole venous access applications like transcatheter edge-to-edge repair, TMVR, and TTVR,” commented Prof. Van Mieghem in Vivasure’s press release. “As these procedures become more common, there’s a need for closure options that can effectively address these emerging clinical applications. I’m looking forward to further study [of] the PerQseal Elite technology for venous closure and [assessing] its performance for patients.”

The PerQseal technology is not available for sale in the United States, advised Vivasure in the press release.