The company has designed the new vascular closure device to close punctures ranging from 10F to 24F at femoral arterial access sites after cardiac catheterization procedures.
The procedures include transcatheter aortic valve replacement (TAVR), endovascular treatment of abdominal aortic aneurysms (AAA/EVAR), ventricular assist (VAD), and balloon aortic valvuloplasty (BAV).
Closure of large bore femoral access sites has been linked 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.
Through using novel closure technology, the Manta device will deal with complexities of closing large punctures in high-pressure vessels.
According to the firm, the device’s fail-safe deployment offers immediate hemostasis to reduce complications associated with large bore closure.
Manta’s EU study principal investigator Dr Nicolas Van Mieghem said: “Our experience in the CE Mark clearly showed Manta can change and improve access site management in the field of large-bore interventions.”
Essential Medical president and CEO Greg Walters said: "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."
