Essential Medical has received CE mark approval for Manta; its large bore vascular closure device. The device is a novel vascular closure device designed to close punctures ranging from 10F to 24F at femoral arterial access sites after cardiac catheterisation procedures such as transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty.
Closure of large bore femoral access sites has been associated with significant morbidity including long times to achieve haemostasis, extended procedure time, need for a vascular surgeon in the catheterization lab, delayed ambulation, higher rate of complications and higher total cost of care. Therefore, Manta was designed to address the complexities of closing large punctures in high-pressure vessels use novel closure technology. According to a press release, the device’s fail-safe deployment provides immediate haemostasis to reduce complications associated with large bore closure.
Nicolas Van Mieghem (Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands), principal investigator in the EU study, comments: “I’m looking forward to have the Manta closure device in my practice for everyday use. Our experience in the CE mark [study] clearly showed Manta can change and improve access site management in the field of large-bore interventions. These challenging procedures will become safer and faster with Manta.”