PerQseal Elite is a sutureless and 100% bioresorbable large-bore vessel closure device designed for patients in large bore percutaneous catheter-based venous interventional procedures
Vivasure Medical announces treatment of the first patient with the PerQseal Elite system. (Credit: National Cancer Institute on Unsplash)
Ireland-based Vivasure Medical has completed the treatment of the first large bore venous patient with the investigational PerQseal Elite vascular closure system.
PerQseal Elite is a sutureless and 100% bioresorbable large-bore vessel closure device.
Vivasure Medical, a firm developing percutaneous vessel closure technology, has designed the vascular closure system for patients in large bore percutaneous catheter-based venous interventional procedures.
The first patient underwent successful implantation at the Thoraxcentre, Erasmus Medical Centre in Rotterdam, The Netherlands. The procedure was undertaken as part of Vivasure Medical’s ELITE Venous Clinical Study.
ELITE Venous is a prospective, multi-centre, single-arm clinical trial assessing the vascular closure system’s safety and efficacy. It will recruit up to 97 participants involving a maximum of 12 European investigational sites.
The study is anticipated to be completed this year, and the findings are expected to help with CE mark and pre-market certification applications.
Vivasure Medical CEO Andrew Glass said: “Cardiovascular procedures have increasingly adopted minimally invasive approaches, but conventional venous closure techniques have presented risks for vascular complications.
“We’re encouraged by the early progress we’ve seen in clinical studies of the Elite vascular closure system to address this unmet need.”
PerQseal Elite uses Vivasure Medical’s PerQseal technology and is intended for sutureless and fully absorbable closure of large-bore venous vessels after percutaneous cardiovascular procedures.
The sutureless system is designed for leadless pacemaker implantation, transcatheter tricuspid valve replacement or repair (TTVR), and transcatheter mitral valve repair or replacement (TMVR).
The device is inserted from inside the vein, making deployment easier to control and simpler than with traditional closure techniques, the Irish medical device maker said. The system also restores the vein to its natural state.