Essential Medical has received investigational device exemption (IDE) approval from the FDA to begin the US clinical trial of its large bore vascular closure device (Manta). The 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 is designed to achieve safe, percutaneous closure in a variety of large bore procedures including transfemoral transcatheter aortic valve implantation (TAVI) and ventricular assist devices.
According to a press release, 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 US$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 haemostasis, extended procedure time, higher rate of complications, and higher total cost of care. However Manta, the press release reports, was specifically designed to address these complexities of closing large punctures in high-pressure vessels using novel closure technology. The device’s simple and fail-safe deployment provides immediate haemostasis in order to reduce the complications and cost associated with large bore closure.
David Wood (a founding member of the Centre for Heart Valve Innovation in Vancouver, Canada), co-principal investigator of the US MANTA trial, says: “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) TAVI Trial is so important. While transfemoral TAVI 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 TAVI can become the default strategy in most patients.”