InSeal Medical wins CE Mark for vascular closure device

InSeal Medical said today it won CE Mark approval in the European Union for its InClosure vascular closure device designed to close large bore arterial punctures. The device is implanted percutaneously and requires no pre-procedure or sheath exchange and features a biodegradable membrane which is coupled to the vessel wall by a thin Nitinol frame, the Israel-based company 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 few exceptions, with fast and reliable hemostasis which translates to a better recovery of the patient,” InClosure clinical study principal investigator Dr. Ran Kornowski of Israel’s Rabin Medical Center said in a press release. InSeal’s InClosure VCD is designed to close large bore arterial punctures ranging from 12F to 21F, a size often used in transcatheter aortic valve replacement and percutaneous endovascular treatment of abdominal aortic aneurysm, the company 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 ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Catheters Regulatory/Compliance InSeal Medical Ltd. Source Type: news