The trail intends to evaluate the safety and efficacy of vascular access closure using Manta device for femoral arterial access sites in patients undergoing percutaneous procedures using sheaths ranging from 10F to 24F.
The device will be used to attain safe and percutaneous closure in different large bore procedures, including transfemoral transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAA), ventricular assist devices (VAD) and balloon aortic valvuloplasty (BAV).
Essential Medical designed the Manta device to address the complexities of closing large punctures in high-pressure vessels by using novel closure technology.
According to the firm, the device's simple and fail-safe deployment offers immediate hemostasis to reduce the complications and cost associated with large bore closure.
The US Manta trial co-principal investigator David Wood said: "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 (3M) TAVR 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."
