Vivasure Medical announced today that it received CE mark approval for its PerQseal Elite vascular closure system. Galway, Ireland-based Vivasure designed the latest-generation PerQseal Elite for percutaneous vessel closure. It leverages the legacy platform’s safety profile and ease of use while allowing for faster delivery. The system improves performance in calcium and the treatment of […]
Vivasure
Vivasure reports positive PerQseal closure device study results
Vivasure Medical reported positive data from an FDA investigational device exemption (IDE) pivotal study evaluating its PerQseal closure device system. Initial results came from the PATCH pivotal study evaluating the safety and efficacy of PerQseal. Investigators presented findings at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C. Galway, Ireland-based Vivasure designed the latest-generation PerQseal Elite […]
Vivasure wins FDA IDE approval, receives €30M from Haemonetics
Vivasure Medical announced today that it received FDA investigational device exemption (IDE) to advance a clinical study of its PerQseal device. Additionally, Galway, Ireland-based Vivasure announced a €30 million ($32.2 million) investment from Haemonetics. It marks part of the company’s Series D financing, for which the initial $23 million tranche closed in May 2022. The […]
Vivasure raises $23M initial Series D tranche; could reach up to $54M
Vivasure Medical announced today that it closed the first tranche — worth $23 million — of its Series D financing round. Galway, Ireland-based Vivasure’s $23 million (€22 million) fundraising tranche could make up a chunk of the Series D that could reach up to $54 million (€52 million) in total. According to a news release, […]
Vivasure treats first patient in U.S. study for next-gen PerQseal+ in TAVR procedures
Vivasure Medical announced today that the first patient was treated in a U.S. early feasibility study of its next-generation PerQseal+ device. Galway, Ireland-based Vivasure’s study will evaluate PerQseal+ in percutaneous transcatheter aortic valve replacement (TAVR) procedures. The first patient was treated by Dr. Robert Pyo at Stony Brook University Hospital in Stony Brook, New York. […]
Vivasure Medical launches PerQseal closure system in the EU
Ireland-based Vivasure Medical said today it launched its PerQseal closure device intended for large-bore transcatheter procedures. The newly launched device is intended for novel transcatheter endovascular procedures including transcatheter aortic valve replacements, thoracic endovascular aneurysm repairs and endovascular abdominal aneurysm repairs, which require large-bore femoral artery access. The system consists of an intravascular patch to seal […]
7 medtech stories we missed this week: Oct. 20, 2017
From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime […]
Vivasure lands $18m Series C
Ireland-based Vivasure Medical said today it raised $18.3 million (EU €16.2 million) in a Series C round of financing, with funding slated to support the European commercialization of its PerQseal technology platform. The Series C round was led by Life Sciences Partners of The Netherlands, invested from its LSP Health Economics Fund, and was co-led […]
Vivasure wins CE Mark for bioabsorbable vascular closure device
Ireland-based Vivasure Medical said today it won CE Mark approval in the European Union for its bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies. The closure device is the 1st from the company’s PerQseal platform, and Vivasure claims its the only approved bioabsorbable, sutureless synthetic option to close large arteriotomies that result from percutaneous […]
