Essential Medical to Seek FDA Approval of Manta Large-Bore Vascular Closure Device
January 8, 2018—Essential Medical, Inc. announced the completion of 60-day follow-up for the MANTA United States pivotal study of the company's Manta vascular closure device.
Gary Roubin, MD, Chief Medical Officer of Essential Medical, advised that the data from this study of 341 patients, along with data from more than 3,000 commercial cases in Europe, continue to provide evidence of the clinical benefits of the Manta device. The company is on track to submit its premarket approval application to the US Food and Drug Administration in the next 90 days. Essential Medical advised that the Manta device has received European CE Mark approval and is currently commercially available for sale in the Netherlands, Norway, Finland, Sweden, Denmark, and Iceland. It is an investigational device in the United States and Canada and is not yet commercially available in those markets.
Manta 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 devices, balloon aortic valvuloplasty, and endovascular aneurysm repair. The device is intended to provide reliable and repeatable deployment with immediate hemostasis in order to reduce complications associated with large-bore closure, stated the company.