Essential Medical has announced the completion of enrolment in the US pivotal investigational device exemption (IDE) trial of the Manta large bore vascular closure device.
The device is a novel CE Marked vascular closure device designed to close punctures ranging from 10Fr to 25Fr at femoral arterial access sites after percutaneous cardiac and peripheral catheterisation procedures that use a large-bore device, such as transcatheter aortic valve implantation (TAVI), endovascular aneurysm repair (EVAR), ventricular assist device, and balloon aortic valvuloplasty.
Zvonomir Krajcer, the lead enroller and co-principal investigator in the MANTA trial, and co-director of the Peripheral Vascular Disease Service at Texas Heart Institute in Houston, USA, says: “I am very encouraged by the results of the 31 Manta cases I personally performed and Dr Strickman’s 23 cases that I observed. At our site, we saw immediate haemostasis, patent vessels, and reduced overall procedure time.”
David Wood, co-principal investigator of the US MANTA trial and a founding member of the Centre for Heart Valve Innovation in Vancouver, Canada, states: “Beautiful device once you learn the nuances. John Webb and I deployed over 30 Manta devices at Vancouver General Hospital and St Paul’s Hospital and we are very encouraged by the results. It will be tough going back to our standard of care while we await commercial approval.”
An emerging field
According to a press release, TAVI is one of the fastest growing segment of the cardiovascular market and helping to drive the potential worldwide market for large bore vascular closure devices to exceed $600 million within five years.
Closure of large bore femoral access sites has been associated with significant morbidity including long times to achieve haemostasis, extended procedure time, need for a vascular surgeon in the catheterisation lab, delayed ambulation, higher rate of complications and higher total cost of care.
Manta was designed to address the complexities of closing these large punctures in high-pressure vessels using novel closure technology. It is intended to provide reliable and repeatable deployment with immediate haemostasis to reduce complications associated with large bore closure.