InSeal Medical Ltd. Announces CE Mark Approval for the InClosure Large Bore Vascular Closure Device

Tuesday, August 09, 2016

InSeal Medical Ltd., a privately held medical device company, announced that it has received CE Mark approval for its InClosure VCD, a large bore vascular closure device. The InClosure VCD is a first-in-class, intravascular closure device based on InSeal Medical's proprietary and patented technology.

Ran Kornowski, MD, Principal Investigator in the InClosure clinical study, Director of the Department of Cardiology at the Rabin Medical Center, Petah Tikva, Israel commented: "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 few exceptions, with fast and reliable hemostasis which translates to a better recovery of the patient."

Avi Penner PhD., CEO of InSeal Medical stated: "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."

The InClosure VCD is a dedicated vascular closure device 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 replacement (TAVR) and percutaneous endovascular treatment of abdominal aortic aneurysms (PEVAR).

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 exploits blood pressure to improve sealing, resulting in a fast and reliable hemostasis even in calcified arteries.


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