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October 26, 2014
Essential Medical's X-Seal Vascular Closure Device Approved in Europe
October 27, 2014—Essential Medical, Inc. announced that it has received European CE Mark approval for its X-Seal vascular closure device. X-Seal closes femoral arterial punctures made during cardiac catheterization procedures such as angiograms, angioplasty, and stenting. The device is designed to provide catheterization lab professionals with superior closure and improved hemostasis, stated the company.
Interventional cardiologist Gary Roubin, MD, is Cofounder of Essential Medical. In the company’s press release, Dr. Roubin commented, “X-Seal represents a truly ‘next-generation’ closure device, offering excellent sealing, angiographic marking, and controlled deployment.”
Essential Medical noted that is also developing the large-bore Manta device for sealing larger femoral arterial punctures made during transcatheter aortic valve replacement, balloon aortic valvuloplasty, and the endovascular treatment of abdominal aortic aneurysms. This large-bore device utilizes sealing components similar to X-Seal and can be easily deployed within 60 seconds. First-in-man studies are starting soon, and a larger European Union study is expected to begin in 2015, advised the company.
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