FDA Approves IDE for Trial of Essential Medical's Manta Large-Bore Vascular Closure Device

July 8, 2016—Essential Medical, Inc. announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin the United States clinical trial for Manta, the company’s large-bore vascular closure device.

According to Essential Medical, the pivotal study will evaluate the safety and efficacy of vascular access closure using Manta for femoral arterial access sites in patients undergoing percutaneous procedures using sheaths ranging from 10 F to 24 F. Manta will be used to achieve percutaneous closure in a variety of large-bore procedures including transfemoral transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR) of abdominal aortic aneurysms, ventricular assist devices, and balloon aortic valvuloplasty.

David Wood, MD, and Zvonimir Krajcer, MD, serve as Coprincipal Investigators of the US MANTA trial. Dr. Wood is a founding member of the Centre for Heart Valve Innovation in Vancouver, British Columbia. Dr. Krajcer is Codirector, Peripheral Vascular Disease Service at the Texas Heart Institute in Houston, Texas.

In the company’s press release, Dr. Wood commented, “We are constantly seeking a safer and more efficient way to replace a patient's failing heart valve, which is why our ongoing Multidisciplinary, Multimodality, but Minimalist: 3MTAVR trial is so important. 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.”

Dr. Krajcer stated, “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 European data. Until now for EVAR, thoracic EVAR, and TVAR 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.”