InSeal Medical has received CE mark approval for its InClosure VCD; a large bore vascular closure device. According to a press release, the InClosure VCD is a first-in-class, intravascular closure device based on InSeal Medical’s proprietary and patented technology.
Ran Kornowski, principal investigator in the InClosure clinical study and director of the Department of Cardiology at the Rabin Medical Center, Petah Tikva, Israel comments, “The InClosure VCD significantly simplified large bore puncture closure which is still one of the last major challenges in transcatheter aortic valve implantation. Based on our growing experience, the InClosure VCD allows for a smoother and safer transcatheter aortic valve implantation procedure without pre-procedure manipulation of the vessel. The closure procedure is simple and controlled with only few exceptions, with fast and reliable haemostasis which translates to a better recovery of the patient.”
The InClosure VCD is designed to close large bore arterial punctures ranging from 12F to 21F. Such large bore delivery systems are used in various catheter-based procedures, including transcatheter aortic valve implantation and percutaneous endovascular treatment of abdominal aortic aneurysms.
The InClosure VCD is implanted percutaneously and requires no pre-procedure or sheath exchange. It is based on a biodegradable membrane coupled to vessel wall by a thin Nitinol frame. The flexible membrane is designed to exploit blood pressure to improve sealing, resulting in a fast and reliable haemostasis even in calcified arteries.