Essential Medical has announced initiation of enrolment in a post-market clinical registry in the regions where Manta is commercially available.
Principal investigator Nicolas Van Mieghem, medical director of the Department of Interventional Cardiology at Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands stated, “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 is time to confirm our results in a multicentre prospective study. We will be enrolling 500 patients in up to 20 centres from the Netherlands, Switzerland, Finland, Denmark, and Sweden.”
Gary Roubin, chief medical officer of the company, stated, “We are excited to keep the momentum going with Nicolas Van Mieghem as we have just finished enrolment in our US IDE trial. We are confident these studies will continue to show that Manta will enable safer and more effective large bore closure with faster ambulation and discharge. Our goal is to show with even greater numbers that Manta will address the access site complications that continue to limit the advancement of large bore procedures because vascular closure technology has not kept pace with valve and stenting technologies.”
Manta is a novel CE-marked vascular closure device designed to close punctures ranging from 10F to 25F at femoral arterial access sites after percutaneous cardiac and peripheral catheterisation procedures that use a large-bore device, such as transcatheter aortic valve implantation, endovascular aneurysm repair, ventricular assist device, and balloon aortic valvuloplasty. Manta is an investigational device in the US and Canada and is not yet commercially available.
The Manta device is CE marked and currently available for sale in the Netherlands, Norway, Finland, Denmark and Sweden. The company recently announced the completion of enrolment in its IDE study and expects to submit its PMA by the end of the first quarter 2018.