Vivasure Medical has received CE mark approval for its PerQseal Elite vascular closure system, providing a new bioresorbable option for percutaneous vessel closure.
Vivasure’s device is designed for sutureless and fully absorbable large-bore closure following percutaneous cardiovascular procedures. Large-bore access is required for a range of cardiovascular interventions including transcatheter aortic valve replacement (TAVR), mitral valve repair or replacement (TMVR), and leadless pacemaker implants, amongst others.
The Irish company’s PerQseal Elite system comprises an absorbable synthetic patch implant that is placed from inside the vein or artery and returns the vessel to its natural state. The implant is then fully absorbed within 180 days. The company said it will launch the product in select European markets this summer.
“The introduction of PerQseal Elite is an exciting advancement for large-bore cardiovascular procedures,” said Dr. Mohamed Abdel-Wahab, professor of Interventional Cardiology and head of the structural heart disease department at the Heart Center in Leipzig, Germany.
“Having a fully absorbable, sutureless closure option simplifies the procedure and has the potential to reduce complications associated with traditional closure methods. We look forward to utilizing this technology to treat our patients.”
The CE mark was based on results from Vivasure’s Frontier clinical programme, which in total saw 216 studies across four studies. The company reported a 97% technical success rate with 1 major procedure related complication. Results from one of the studies, published in the Journal of the American College of Cardiology (JACC), concluded that potential advantages of PerQseal compared with established closure techniques are the short learning curve and the ability to deploy the single device at the end of the procedure. A US Investigational Device Exemption (IDE) pivotal trial has also yielded positive results.
Vivasure states that no materials like collagen, metal implants or sutures are left behind. Haemonetics Corporation is one of the companies using collagen for its vessel closure technology, which it says is also bioresorbable. Haemonetics has a headstart on Vivasure with its Vascade closure device already at market in Europe, courtesy of a CE mark in 2022.
In 2023, Vivasure secured a €30m ($34m) strategic investment from Haemonetics, as part of a deal that gives Haemonetics the option to buy Vivasure if certain milestones are hit.
Meanwhile, Vascade has been used in the US for over a decade after a clearance from the US Food and Drug Administration (FDA) in 2023. Vivasure’s PerQseal Elite is not yet approved in the US. Other major medtech companies in the large-bore closure market segment, such as Abbott with its ProGlide range and Teleflex with its MANTA device.
The global arteriotomy closure device market was estimated to be worth $1.8bn in 2024, and is forecast to rise to $2.5bn by 2034, according to analysis by GlobalData.
