October 2, 2017
Enrollment Completed in Pivotal Trial of Essential Medical's Manta Large-Bore Vascular Closure Device
October 2, 2017—Essential Medical, Inc. announced the completion of enrollment in the United States pivotal trial of its Manta large-bore vascular closure device. The trial, which is being conducted under an investigational device exemption, has enrolled 341 patients at 21 sites with 43 investigators in 10 months. The company expects to file a premarket approval submission to the US Food and Drug Administration by the end of the first quarter in 2018.
The Manta vascular closure device is designed to close punctures ranging from 10 to 25 F at femoral arterial access sites after percutaneous cardiac and peripheral catheterization procedures that use a large-bore device, such as transcatheter aortic valve replacement, ventricular assist device, balloon aortic valvuloplasty, and endovascular aneurysm repair.
The Manta device has received European CE Mark approval and is currently available for sale in the Netherlands, Norway, Finland, Denmark, and Sweden. In the United States and Canada, it is an investigational device and is not yet commercially available.
Zvonomir Krajcer, MD, is the lead enroller and Co-Principal Investigator in the trial and is Co-Director of the Peripheral Vascular Disease Service at Texas Heart Institute in Houston, Texas. Neil E. Strickman, MD, is also an investigator at Texas Heart Institute. Dr. Krajcer commented in the company's announcement, "I'm very encouraged by the results of the 31 Manta cases I personally performed and Dr. Strickman's 23 cases that I observed. At our site, we saw immediate hemostasis, patent vessels, and reduced overall procedure time."
David Wood, MD, is a Co-Principal Investigator of the United States trial and a founding member of the Center for Heart Valve Innovation in Vancouver, Canada, where John Webb, MD, is also a trial investigator. Dr. Wood stated, "Beautiful device once you learn the nuances. John Webb and I deployed over 30 Manta devices at Vancouver General Hospital and St. Paul's Hospital and we are very encouraged by the results. It will be tough going back to our standard of care while we await commercial approval."