Vivasure Medical has treated the first venous patient in a clinical trial investigating its PerQseal Elite vascular closure system for large-bore vessel closure.
Large-bore access is required for a range of cardiovascular interventions including transcatheter mitral valve repair or replacement (TMVR), transcatheter tricuspid valve repair or replacement (TTVR) and leadless pacemaker implants.
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Ireland-based Vivasure says that there are currently no sutureless options available to close vessels following large-bore venous procedures.
The company’s PerQseal Elite system is placed from inside the vein or artery and returns the vessel to its natural state via fully absorbable means. Unlike other techniques, it does not leave collagen, metal implants or sutures behind.
The device is being evaluated in the ELITE Venous clinical study. The prospective, multi-centre, single-arm trial will assess the safety and effectiveness of the system in patients undergoing percutaneous catheter-based interventional procedures. A total of 97 patients are estimated to enrol at 12 European sites.
Vivasure expects to complete the study later this year, with results to support regulatory submissions.
The company treated the first patient requiring large-hole arterial closure in December 2023. Both the first large-bore arterial and venous treatments in the trial were conducted at the Erasmus University Medical Center in the Netherlands.
Vivasure raised €30m ($32.4m) in March 2023 via a strategic investment from US-based blood and plasma supplier Haemonetics. The investment was part of a Series D financing round, adding to €22m raised in May 2022.
Vivasure also secured an investigational device exemption from the US Food and Drug Administration (FDA) in March 2023. The company recruited the first patients in a US pivotal study of its PerQseal system, called PATCH, last May. Vivasure plans to enrol up to 188 patients in the trial, with study completion expected by the end of this year.
Vivasure’s 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.”
Also in the space is Teleflex’s MANTA vascular closure device for large-bore femoral arterial access site closure.
