The FDA has granted Investigational Device Exemption approval to Essential Medical, Inc. to begin the U.S. clinical trial for MANTA, the company’s large bore vascular closure device.
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 10F to 24F.
The device will be used to achieve safe, percutaneous closure in a variety of large bore procedures including transfemoral transcatheter aortic valve replacement (TAVR), endovascular aortic repair of abdominal aortic aneurysms, ventricular assist devices, and balloon aortic valvuloplasty.
These large bore procedures are the fastest growing segment of the cardiovascular market and are driving a worldwide market for large bore vascular closure devices to exceed $600 million within the next five years.
Closure of large bore femoral access sites has been associated with significant increases in morbidity including longer times to achieve hemostasis, extended procedure time, higher rate of complications, and higher total cost of care.
MANTA was specifically designed to address these complexities of closing large punctures in high-pressure vessels utilizing novel closure technology. Deployment of the device provides immediate hemostasis in order to reduce the complications and cost associated with large bore closure.
“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,” according to Dr. David Wood, an investigator for the U.S. MANTA trial and a founding member of the Centre for Heart Valve Innovation in Vancouver, Canada. “Safe, reproducible percutaneous large bore closure is needed before transfemoral TAVR can become the default strategy in most patients.”
Essential Medical, Inc. is a privately held medical device company addressing the large bore vascular closure market. The company was founded in 2010.