Essential Medical said today that it won an investigational device exemption for a clinical trial of its Manta vascular closure device.
The Manta 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.
The U.S. pivotal study is designed to assess the safety and efficacy of the Manta device 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, Malvern, Pa.-based Essential Medical said.
A separate, 50-patient trial aimed at winning CE Mark approval in the European Union closed enrollment in February; the company said it applied for CE Marking in May.
“I’m very excited to be a part of the Manta vascular closure trial as I believe it will deliver fewer complications and faster overall procedure times based on the EU data. Until now for EVAR, TEVAR and TAVAR we had to use the vascular closure devices that were not originally designed for this indication. Finally, for the first time with Manta we will have the opportunity to use a reliable and simple vascular closure device for large-bore sheaths. This device will in a safer way advance the treatment of many patients with aortic aneurysmal and valvular heart disease,” co-principal investigator Dr. Zvonimir Krajcer, of Houston’s Texas Heart Institute, said in prepared remarks.
“While transfemoral TAVR has advanced rapidly and can now be safely performed in fully awake patients in less than 30 minutes, the vascular closure method for these cases has not progressed and access site related complications remain a concern. Safe, reproducible percutaneous large bore closure is needed before transfemoral TAVR can become the default strategy in most patients,” added co-principal investigator Dr. David Wood of Vancouver’s Centre for Heart Valve Innovation.