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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...
Source: Mass Device - August 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance InSeal Medical Ltd. Source Type: news

FDA approves Vasorum ’ s Celt ACD vascular closure device
Vasorum said today that it won pre-market approval from the FDA for its Celt ACD vascular closure device. The Dublin-based company said the Celt ACD is designed to close punctures to the femoral artery after catheterization, using a biocompatible implant on both the inside and outside of the arterial wall. Vasorum said the PMA approval was based on a 207-patient trial in the U.S. and Europe led by Dr.Shing-Chiu Wong of the NewYork-Presbyterian/Weill Cornell Medical Center. The device has already won CE Mark approval in the European Union, Vasorum said. “With more than 20,000 patient...
Source: Mass Device - July 21, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Vasorum Source Type: news