Featuring the firm’s patented technology, the InClosure VCD will close large bore arterial punctures ranging from 12F to 21F.
Large bore delivery systems are used in different catheter based procedures such as transcatheter aortic valve replacement (TAVR) and percutaneous endovascular treatment of abdominal aortic aneurysms (PEVAR).
The InClosure VCD, which is implanted percutaneously, requires no pre-procedure or sheath exchange. It is based on a biodegradable membrane paired to vessel wall by a thin nitinol frame.
The flexible membrane is said to exploit blood pressure to enhance sealing, providing reliable hemostasis even in calcified arteries.
InClosure clinical study principal investigator Ran Kornowski said: "The InClosure VCD significantly simplified large bore puncture closure which is still one of the last major challenges in TAVR.
InSeal Medical CEO Avi Penner said: “CE mark approval of the InClosure VCD allows a safer and more effective arteriotomy closure for patients undergoing transcatheter aortic valve replacement and percutaneous aortic aneurysm repair.
“While TAVR and EVAR systems have progressed, the procedures are still limited by suboptimal vascular closure technologies. We're very excited to help change this as the InClosure VCD becomes available in Europe."
InSeal Medical is engaged in the development of novel closure solutions for cardiovascular applications by using its InClosure technology.
