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August 10, 2016

CE Mark Approval for InSeal Medical's Large-Bore InClosure VCD

August 8, 2016—InSeal Medical Ltd. (Caesarea, Israel) announced that it has received CE Mark approval for its dedicated large-bore vascular closure device (VCD).

According to the company, the InClosure VCD is designed to close large-bore arterial punctures ranging from 12 to 21 F in catheter-based procedures, including percutaneous endovascular treatment of abdominal aortic aneurysms and transcatheter aortic valve replacement (TAVR).

In the company’s press release, Ran Kornowski, MD, Principal Investigator in the InClosure clinical study, 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 preprocedure 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.” Dr. Kornowski is Director of the Department of Cardiology at the Rabin Medical Center in Petah Tikva, Israel.

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August 11, 2016

FDA Issues Draft Updated Recommendations on 510(k) Clearance of Device Modifications

August 11, 2016

FDA Issues Draft Updated Recommendations on 510(k) Clearance of Device Modifications