Essential Medical Completes Enrollment In US IDE Trial For The MANTA Large Bore Vascular Closure Device Used Primarily In Percutaneous Heart Valve Replacement Procedures
Published: Oct 02, 2017
MALVERN, Pennsylvania, Oct. 2, 2017 /PRNewswire/ -- Essential Medical today announced the completion of enrollment in the US pivotal IDE trial of the MANTA large bore vascular closure device.
"Our team is thrilled with the enthusiasm of investigators and sites that accelerated MANTA study enrollment," commented Todd Sorzano, Director of Operations at Essential Medical. "Because of their excitement to use MANTA, we enrolled 341 patients at 21 different sites with 43 investigators in 10 months."
Greg Walters, President and CEO, "I thank the efforts of the entire team at Essential Medical in supporting all the clinical sites, which enabled the trial to be completed approximately three months ahead of schedule. We expect to file our PMA submission by the end of the first quarter in 2018."
Dr. 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, TX, 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."
Dr. David Wood, Co-Principal Investigator of the US 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), and balloon aortic valvuloplasty (BAV). MANTA is an investigational device in the US and Canada and is not yet commercially available.
These procedures are the fastest growing segment of the cardiovascular market and are driving the potential worldwide market for large bore vascular closure devices to exceed $600 million within 5 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. MANTA is intended to provide reliable and repeatable deployment with immediate hemostasis in order to reduce complications associated with large bore closure.
The MANTA device is CE marked and currently available for sale in the Netherlands, Norway, Finland, Denmark and Sweden.
About Essential Medical
Essential Medical, Inc., is a privately held company focused both on evolving the small bore vascular closure device market and transforming the large bore vascular closure market by delivering products that meet the unmet need for fast closure without complications. The company was founded in 2010 by Greg Walters, a senior product development executive with 25 years experience creating innovative cardiovascular products, and Dr. Gary Roubin, MD, PhD, a coronary and carotid stenting pioneer.
View original content with multimedia:http://www.prnewswire.com/news-releases/essential-medical-completes-enrolment-in-us-ide-trial-for-the-manta-large-bore-vascular-closure-device-used-primarily-in-percutaneous-heart-valve-replacement-procedures-300528991.html
SOURCE Essential Medical