December 22, 2017 — Essential Medical announced the completion of enrollment in the U.S. pivotal investigational device exemption (IDE) trial of the Manta large bore vascular closure device. The company said it has enrolled 341 patients at 21 different sites with 43 investigators in 10 months. Essential Medical President and CEO Greg Walters said the company expects to file a premarket approval (PMA) submission with the U.S. Food and Drug Administration (FDA) by the end of the first quarter in 2018.
Zvonimir Krajcer, M.D., 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, stated, "I'm 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 hemostasis, patent vessels and reduced overall procedure time."
David Wood, M.D., co-principal investigator of the U.S. MANTA trial and a founding member of the Centre for Heart Valve Innovation in Vancouver, Canada, stated, "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."
Manta is a novel CE Marked vascular closure device designed to close punctures ranging from 10F to 25F at femoral arterial access sites after percutaneous cardiac and peripheral catheterization procedures that use a large-bore device, such as transcatheter aortic valve implantation (TAVI), endovascular aneurysm repair (EVAR), ventricular assist device (VAD) implantation and balloon aortic valvuloplasty (BAV). Manta is an investigational device in the United States and Canada and is not yet commercially available.
These procedures are the fastest growing segment of the cardiovascular market, according to Essential Medical, and are driving 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 hemostasis, extended procedure time, need for a vascular surgeon in the catheterization 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 utilizing novel closure technology. The device is intended to provide reliable and repeatable deployment with immediate hemostasis in order to reduce complications associated with large bore closure.
Manta is CE marked and currently available for sale in the Netherlands, Norway, Finland, Denmark and Sweden.
For more information: www.essmedclosure.com