Articles from Vivasure Medical

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that the company has been acquired by Haemonetics Corporation (NYSE: HAE) in a transaction valued up to €185M (~$215M) on completion of certain milestones.

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its PerQseal® Elite vascular closure system for arterial procedures. The submission builds upon the successful results of the PATCH study as well as positive clinical use in Europe, reinforcing the system’s potential safety and performance profile. In addition, the company received European CE mark approval for an expanded indication for PerQseal Elite covering large-bore venous closure. This follows its first CE mark approval in April 2025 for arterial procedures and positions PerQseal Elite as the first fully bioresorbable, sutureless solution in Europe for both arterial and venous access closure.

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced European CE mark approval of the PerQseal® Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure device. The company plans to launch the product in select European markets this summer.

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced initial positive results from its U.S. IDE PATCH Pivotal Study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System, at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual conference in Washington, D.C.

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that it will unveil the results of its U.S. PATCH Study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual conference in Washington, D.C., October 27-30, 2024. Lead investigators of the PATCH Study as well as the ELITE and ELITE Venous studies will discuss outcomes and share insights from their experience at the forefront of introducing a non-invasive, controlled technique for large-bore venous 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.

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the first patient treated with PerQseal® Elite, the latest generation of the company’s fully absorbable large-hole closure system. The first successful implants were completed by Prof. Nicolas Van Mieghem, M.D. Ph.D., at Erasmus University Hospital in Rotterdam, The Netherlands, as part of the company’s ELITE Study—a prospective, multi-center, single-arm clinical study evaluating the safety and efficacy of PerQseal Elite.

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the 100th patient in its PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System. The U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval earlier this year to advance the PATCH study forward.

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the first patients in the company’s PerQseal® PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal Closure Device System. The first patients were enrolled at Kaleida Health's Buffalo General Medical Center-Gates Vascular Institute in Buffalo, New York by Dr. Vijay Iyer, Chief of Cardiology at the University of Buffalo and Director, Structural Heart Interventions at Buffalo General Hospital.

Vivasure Medical® Limited (“Vivasure” or the “Company”), a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal® Closure Device System.

Vivasure Medical® (“Vivasure” or the “Company”), a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the closing of the first tranche of €22 million ($23M) as part of its Series D financing round that could reach up to €52 million ($54M) in total. Led by a multi-national strategic corporation, the financing includes an option to buy the Company upon certain milestones. Other participants in this Series D financing round include a second strategic corporate investor as well as existing investors, Fountain Healthcare Partners, Orchestra BioMed, LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners and Evonik Venture Capital.

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that the first patient was treated in a U.S. early feasibility study evaluating PerQseal®+, the next generation of the company’s PerQseal device. The study is designed to evaluate PerQseal+ in percutaneous transcatheter aortic valve replacement (TAVR) procedures. PerQseal+ is intended to provide physicians with an even more robust solution for managing challenges and bleeding complications associated with large-bore arterial vessel closure.

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced its development program for PerQseal® Blue, the company’s new investigational product. PerQseal Blue is designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such transcatheter mitral valve repair or replacement (TMVR) and transcatheter tricuspid valve repair or replacement (TTVR). The PerQseal Blue technology is based on PerQseal, the company’s vascular closure device approved in Europe for use in femoral arteries.

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the first patient was enrolled in the Frontier V study, a European multicenter study evaluating PerQseal®+, the next generation of the company’s PerQseal® device.