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July 19, 2016
Essential Medical's Manta Large-Bore Vascular Closure Device Approved in Europe
July 18, 2016—Essential Medical, Inc. announced that it has received European CE Mark approval for the company’s Manta large-bore vascular closure device. Manta is designed to close punctures ranging from 10 F to 24 F at femoral arterial access sites after cardiac catheterization procedures such as endovascular repair of abdominal aortic aneurysms, transcatheter aortic valve replacement ventricular assist, and balloon aortic valvuloplasty.
According the company, Manta’s closure technology addresses the complexities of closing large punctures in high-pressure vessels utilizing novel closure technology. The device’s fail-safe deployment provides immediate hemostasis in order to reduce complications associated with large-bore closure.
In the company’s press release, Nicolas Van Mieghem, MD, Principal Investigator in the European Union study of Manta, commented, “I'm looking forward to have the Manta closure device in my practice for everyday use. Our experience in the CE Mark [trial] clearly showed Manta can change and improve access site management in the field of large-bore interventions. These challenging procedures will become safer and faster with Manta.” Dr. Van Mieghem is Medical Director of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center in Rotterdam, the Netherlands.
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