Israel-based medical device company InSeal has secured the CE Mark for its InClosure VCD, a large bore vascular closure device.
Based on the company's proprietary and patented technology, the device has been designed to block the large bore arterial punctures ranging from 12F to 21F.
The large bore delivery systems are used in various catheter based procedures, such as transcatheter aortic valve replacement (TAVR) and percutaneous endovascular treatment of abdominal aortic aneurysms (PEVAR).
The InClosure VCD is inserted into the artery through a fully percutaneous TAVR or EVAR procedure requiring no pre-procedure or sheath exchange.
It features a biodegradable membrane that covers the puncture. After being implanted, the membrane biodegrades within several months.
The membrane is supported against the vessel wall composed of a thin Nitinol frame.
The flexible membrane leverages on blood pressure to block the vascular puncture which results in a fast and reliable hemostasis even in calcified arteries.
Rabin Medical Center cardiology department director and 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.
“Based on our growing experience, the InClosure VCD allows for a smoother and safer TAVR procedure without pre-procedure manipulation of the vessel.
“The closure procedure is simple and controlled with only a few exceptions, with fast and reliable hemostasis which translates to a better recovery of the patient."
The company noted that pre-clinical studies conducted on animals evaluated the InSeal VCD delivery, acute hemostasis, chronic hemostasis and healing.