Essential Medical, Inc., a privately held medical device company addressing the rapidly growing $600M large bore vascular closure market, announced today the start of the MANTA Vascular Closure Device U.S. Pivotal Trial.
The first U.S. case was performed on November 28 by Dr. Itsik Ben-Dor, MD at the Washington Hospital Center in Washington D.C. After successfully implanting a 34mm Medtronic CoreValve Evolut R, the 21F arteriotomy was closed with the 18F MANTA device, which provided immediate hemostasis and a clear patent vessel.
Dr. 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 stated, “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 TAVR.”
The second TAVR patient was enrolled at Texas Heart in Houston, Texas. Dr. 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 hemostasis.
After the first two implantations in North America, Dr. Krajcer led efforts in the first MANTA closure following an EVAR procedure. The successful EVAR was performed using an Ovation iX stent graft, creating a 14F arteriotomy closed with the 14F MANTA. Hemostasis was achieved in under 30 seconds.
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