CE Mark Approval for Essential Medical’s Large Bore Vascular Closure Device

Essential Medical Inc., a privately held medical device company addressing the rapidly growing large bore vascular closure market, has received CE mark approval for Manta, the company’s large bore vascular closure device.
 
Nicolas Van Mieghem, M.D., Ph.D., principal investigator in the EU study and medical director of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands commented, “I’m looking forward to have the Manta closure device in my practice for everyday use. Our experience in the CE mark 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.”
 
Greg Walters, president and CEO of Essential Medical, stated, “We are thrilled to have approval to sell Manta and have already ramped up production for sales and distribution in Europe. It’s been a great few weeks at Essential Medical with FDA’s approval to start our domestic Manta trial and now CE mark approval.”
 
Manta is a novel vascular closure device designed to close punctures ranging from 10F to 24F at femoral arterial access sites after cardiac catheterization procedures such as transcatheter aortic valve replacement (TAVR), endovascular treatment of abdominal aortic aneurysms (AAA/EVAR), ventricular assist (VAD), and balloon aortic valvuloplasty (BAV). These procedures are the fastest growing segment of the cardiovascular market and are driving the potential worldwide market for large bore vascular closure devices to exceed $600 million within five years. Closure of large bore femoral access sites has been associated with significant morbidity including long times to achieve hemostasis, extended procedure time, need for a vascular surgeon in the catheterization lab, delayed ambulation, higher rate of complications and higher total cost of care. Manta was designed to address the complexities of closing large punctures in high-pressure vessels utilizing novel closure technology. Manta’s fail-safe deployment provides immediate hemostasis in order to reduce complications associated with large bore closure.