Essential Medical Release: The MANTA Large Bore Vascular Closure Device To Be Evaluated In A 500-Patient European Post Market Clinical Registry
Published: Oct 09, 2017
EXTON, Pennsylvania, Oct. 9, 2017 /PRNewswire/ --Essential Medical, Inc. today announced initiation of enrollment in a post market clinical registry in the regions where MANTA is commercially available.
Principle Investigator Nicolas Van Mieghem, MD, PhD, Medical Director of the Department of Interventional Cardiology at Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands stated, "MANTA has quickly become our standard of care at the Thoraxcenter. In our experience, MANTA proved to be safe, effective, and easy to use, but now it's time to confirm our results in a multi-center prospective study. We will be enrolling 500 patients in up to 20 centers from the Netherlands, Switzerland, Finland, Denmark, and Sweden."
Dr. Gary Roubin, Chief Medical Officer of the company, stated, "We're excited to keep the momentum going with Dr. Van Mieghem as we've just finished enrollment in our US IDE trial. We're confident these studies will continue to show that MANTA will enable safer and more effective large bore closure with faster ambulation and discharge. Our goal is to show with even greater numbers that MANTA will address the access site complications that continue to limit the advancement of large bore procedures because vascular closure technology has not kept pace with valve and stenting technologies."
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. The company recently announced the completion of enrollment in its IDE study and expects to submit its PMA by the end of the first quarter 2018.
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.
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SOURCE Essential Medical, Inc.