US-based medical device company Essential Medical has secured investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate the clinical trial of its large bore vascular closure device, Manta.
Manta is a vascular closure device, based on anchor / plug sealing technologies, which uses common absorbable biomaterials and is equipped with x-ray visibility and improved deployment control.
The pivotal trial is intended to assess the safety and efficacy of Manta as it is deployed at femoral arterial access sites in patients undergoing percutaneous procedures using sheaths ranging from 10F to 24F.
Manta is expected to provide a safe, percutaneous closure in a variety of large bore procedures.
It is applicable on a range of procedures namely transfemoral transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAA), ventricular assist devices (VAD), and balloon aortic valvuloplasty (BAV).
Centre for Heart Valve Innovation in Vancouver Canada founding member and US Manta trial co-principal investigator Dr David Wood said: "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."
Manta is intended to address the complexities associated with large bone procedures like morbidity, longer procedure time and cost.
The company noted that its simple and fail-safe deployment results to an immediate hemostasis which will reduce the complications and cost associated with large bore closure.