Investigational technology designed for patients undergoing emerging large bore percutaneous catheter-based venous interventional procedures
Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has treated the first large bore venous patient with the PerQseal® Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure device. The first successful implant was completed by Prof. Nicolas Van Mieghem, M.D. Ph.D., Clinical Director of Interventional Cardiology at the Thoraxcentre, Erasmus Medical Centre in Rotterdam, The Netherlands, as part of the company’s ELITE Venous Clinical Study—a prospective, multi-center, single-arm clinical study evaluating the safety and efficacy of the vascular closure system.
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 Prof. Nicolas Van Mieghem, principal investigator of the ELITE Study. “I’m looking forward to further study 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,” said Andrew Glass, chief executive officer of Vivasure Medical. “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. Completion of the study is expected this year, and results will support CE mark and pre-market approval submissions.
About Vivasure Medical
Based in Galway, Ireland, Vivasure is focused on the development of 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 leading international medtech investors. For more information, please visit www.vivasuremedical.com.
The PerQseal® is not available for sale in the United States.