United States Pivotal Trial Begins for Essential Medical’s Manta Vascular Closure Device
December 12, 2016–Essential Medical, Inc. announced the start of the MANTA United States pivotal trial for the company's Manta vascular closure device. According to the company, the Manta device is designed to close punctures ranging from 10 to 24 F at femoral arterial access sites after cardiac catheterization procedures, such as endovascular aortic repair (EVAR) treatment of abdominal aortic aneurysms, transcatheter aortic valve replacement (TAVR), ventricular assist, and balloon aortic valvuloplasty.
Zvonimir Krajcer, MD, who is Coprincipal Investigator of the MANTA trial and Co-Director of the Peripheral Vascular Disease Service at Texas Heart in Houston, Texas, led efforts in the first MANTA trial closure after an EVAR procedure. The successful EVAR was performed using an Ovation iX stent graft (Endologix, Inc.), creating a 14-F arteriotomy closed with the 14-F Manta device. Hemostasis was achieved in < 30 seconds, reported Essential Medical.
Additionally, Itsik Ben-Dor, MD, performed the first United States TAVR case on November 28 at the Washington Hospital Center in Washington, DC. After successfully implanting a 34-mm CoreValve Evolut R TAVR device (Medtronic), the 21-F arteriotomy was closed with the 18-F Manta device, which provided immediate hemostasis and a clear patent vessel.
The second TAVR patient in the trial was enrolled by Dr. Krajcer. He successfully closed a 23-F arteriotomy with the 18-F Manta device and achieved immediate hemostasis, reported the company.