European Postmarket Registry Begins for Essential Medical's Manta Large-Bore Vascular Closure Device
October 9, 2017—Essential Medical, Inc. announced the initiation of enrollment in a postmarket clinical registry of the company's Manta large-bore vascular closure device to be conducted in the regions where the device commercially available. The Manta device has received European CE Mark approval and is currently available for sale in the Netherlands, Norway, Finland, Denmark, and Sweden.
The registry's Principal Investigator is Nicolas Van Mieghem, MD, who is Medical Director of the Department of Interventional Cardiology at Thoraxcenter, Erasmus Medical Center in Rotterdam, Netherlands. In the company's announcement, Dr. van Mieghem commented, "Manta has quickly become our standard of care at the Thoraxcenter. In our experience, Manta proved to be safe, effective, and easy to use, but now it's time to confirm our results in a multicenter prospective study. We will be enrolling 500 patients in up to 20 centers from the Netherlands, Switzerland, Finland, Denmark, and Sweden."
According to the company, 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.
In the United States and Canada, Manta is an investigational device. The company recently announced the completion of enrollment in its United States pivotal trial conducted under an investigational device exemption and expects to submit its premarket approval application by the end of the first quarter of 2018.