CE Mark Approval Data Published for Essential Medical's Manta Large-Bore Vascular Closure Device
April 3, 2017—Essential Medical, Inc. announced the publication of the CE Mark approval study of the Manta vascular closure device, "Percutaneous Plug-Based Arteriotomy Closure Device for Large-Bore Access" by Nicolas M. Van Mieghem, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions.
According to the company, this prospective evaluation of vascular access complications after large-bore cardiovascular procedures (high-risk percutaneous coronary intervention, balloon aortic valvuloplasty, or transcatheter aortic valve replacement) demonstrated extremely low rates of vascular access and bleeding complications with Essential Medical's Manta closure device. In the study, 50 patients were treated at three centers, with one VARC-2 major complication and no VARC-2 minor complications reported. The mean and median time-to-hemostasis was 2 minutes 23 seconds and 24 seconds, respectively, with 74% of patients having hemostasis in < 1 minute. The investigators noted that the results compared extremely favorably to outcomes observed with currently used methods.
In Essential Medical's announcement, William W. O'Neill, MD, commented, "The device is extremely easy to use compared to current methods. The results of this study and real-world registry data emerging from commercialization in Europe are extraordinarily encouraging." Dr. O'Neill serves as Chairman of the Scientific Advisory Board at Essential Medical and is the Medical Director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, Michigan.
The company noted that closure of large-bore femoral access sites has been associated with significant morbidity, including higher rate of complications and higher total cost of care. A recent study published online by Björn Redfors, MD, et al in Journal of the American Medical Association: Cardiology demonstrated the need for a reliable large-bore closure device to reduce the current 17.7% bleeding complication seen and the unsettling costs. Compared to the median total health care costs of $29,968 for patients without bleeding complications, the median total health care costs were $48,663 for patients with bleeding complications.
The Manta vascular closure device, which received CE Mark approval and is commercially available in the Netherlands, is designed to close punctures ranging from 10 to 25 F at femoral arterial access sites after cardiac catheterization procedures such as transcatheter aortic valve replacement, endovascular treatment of abdominal aortic aneurysms, ventricular assist, and balloon aortic valvuloplasty. An investigational device exemption study is currently underway in the United States, advised Essential Medical.