Essential Medical has announced the start of the Manta vascular closure device US pivotal trial.
The first US case was performed on November 28 by Itsik Ben-Dor, at the Washington Hospital Center in Washington, DC, USA. After successfully implanting a 34mm Medtronic CoreValve Evolut R, the 21F arteriotomy was closed with the 18F Manta device, which provided immediate haemostasis and a clear patent vessel, according to a company release.
David Wood, co-principal investigator of the US Manta trial and a founding member of the Centre for Heart Valve Innovation in Vancouver, Canada, was on site for the case and states, “The team in Washington did a great job implanting the first 18F Manta closure device in North America. The result was excellent, and we are keen to start enrolling patients in the trial. This technology has the potential to be a real game changer for transfemoral transcatheter aortic valve implantation (TAVI).”
The second TAVI patient was enrolled at Texas Heart in Houston, USA. Zvonko Krajcer, co-principal investigator of the Manta trial and co-director of the peripheral vascular disease service at Texas Heart performed this procedure. He successfully closed a 23F arteriotomy with the 18F Manta and achieved immediate haemostasis.
After the first two implantations in North America, Krajcer led efforts in the first Manta closure following an endovascular aortic repair (EVAR) procedure. The EVAR was performed using an Ovation iX stent graft, creating a 14F arteriotomy closed with the 14F Manta. Haemostasis was achieved in under 30 seconds.
Manta is a novel CE-marked vascular closure device designed to close punctures ranging from 10F to 24F at femoral arterial access sites after cardiac catheterisation procedures such as TAVI, EVAR, ventricular assist, and balloon aortic valvuloplasty. The Manta is currently available for sale in the Netherlands.