Vivasure Medical’s PerQseal Elite Used in First Large Hole Venous Treatment

Vivasure Medical’s PerQseal Elite vascular closure system has been used for the first time in treating a large bore venous patient.

Prof. Nicolas Van Mieghem, M.D. Ph.D., clinical director of Interventional Cardiology at the Thoraxcentre, Erasmus Medical Centre in Rotterdam, The Netherlands, performed the first implant as part of the company’s ELITE Venous Clinical Study—a prospective, multi-center, single-arm clinical trial evaluating the safety and efficacy of the device. 
 
Leveraging Vivasure Medical’s PerQseal technology, the PerQseal Elite vascular closure system is designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures such as transcatheter mitral valve repair or replacement (TMVR), transcatheter tricuspid valve repair or replacement (TTVR), and leadless pacemaker implants. Currently, there are no sutureless options available for vessel closure following large-bore venous procedures.
 
“Current venous closure methods are not indicated for large hole venous access applications like Transcatheter Edge-to-Edge repair (TEER), TMVR and TTVR. As these procedures become more common, there’s a need for closure options that can effectively address these emerging clinical applications,” said Van Mieghem, ELITE study principal investigator. “I’m looking forward to further study of the PerQseal ELITE technology for venous closure and assess its performance for patients.”
 
The PerQseal Elite vascular closure system is placed from inside the vein, making deployment simpler and more controlled than conventional closure techniques and returning the vein to its natural state without leaving materials like collagen, metal implants or sutures behind, as commonly seen in other closure technologies.
 
“Cardiovascular procedures have increasingly adopted minimally invasive approaches, but conventional venous closure techniques have presented risks for vascular complications,” Vivasure Medical CEO Andrew Glass stated. “We’re encouraged by the early progress we’ve seen in clinical studies of the Elite vascular closure system to address this unmet need. I’m grateful to Prof. Van Mieghem for treating the first patient in this study and look forward to following the outcomes from other patients in this study.”
 
Vivasure’s Elite Venous Clinical Study will enroll up to 97 patients at up to 12 European investigational sites. The study is expected to be completed this year, and results will support CE mark and pre-market approval submissions.
 
Based in Galway, Ireland, Vivasure develops advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology, and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by international medtech investors. The PerQseal device is not available for sale in the United States.