Essential Medical said today that it won CE Mark approval in the European Union for its Manta vascular closure device.
The device is designed to close punctures in less than 1 minute, providing immediate hemostasis, using absorbable biomaterials in an “anchor/plug” sealing technology, according to Essential Medical’s website.
“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,” president & CEO Greg Walters said in prepared remarks.
“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,” added principal EU study investigator Dr. Nicolas Van Mieghem of the Erasmus Medical Center in Rotterdam, Holland.
Earlier this month Malvern, Pa.-based Essential Medical won an investigational device exemption from the FDA for a U.S. pivotal trial of the device.
The study is designed to assess safety and efficacy in closing access sites on the femoral artery for percutaneous procedures including transcatheter aortic valve replacement, endovascular aortic repair, ventricular assist devices and balloon aortic valvuloplasty.