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MALVERN, Pennsylvania, August 8, 2017 /PRNewswire/ --
Essential Medical announces more than 1,000 MANTA large bore vascular closure devices have been successfully deployed globally. To meet the growing demands of the $600 million large bore closure market, Essential Medical is also increasing their production capacity with a new facility located in Exton, PA.
"We are extremely pleased to announce the use of over 1,000 MANTA devices from the sales of our EU commercial launch, our successful CE Mark study, and our ongoing US IDE study," commented Greg Walters, President and CEO of Essential Medical. "Our sales distribution in the Netherlands, Finland, Sweden, Norway, and Denmark continue to exceed our expectations. Due to the increased demand for MANTA and our anticipated approval for MANTA in the United States in 2018, we are moving our headquarters and manufacturing to a larger facility. This move will be completed in September 2017."
Dr. Gary Roubin, Chief Medical Officer of Essential Medical commented "It is reassuring that we see excellent outcomes and enthusiastic physician adoption of the MANTA device. Results are very consistent with what we experienced in the EU clinical trial."
MANTA is a novel CE Marked vascular closure device designed to close punctures ranging from 10F to 24F at femoral arterial access sites after cardiac catheterization procedures such as transcatheter aortic valve replacement (TAVR), endovascular treatment of abdominal aortic aneurysms (AAA/EVAR), ventricular assist (VAD), and balloon aortic valvuloplasty (BAV). MANTA is an investigational device in the US and Canada.
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 large punctures in high-pressure vessels utilizing novel closure technology. MANTA's fail-safe deployment provides immediate hemostasis in order to reduce complications associated with large bore closure.
About Essential Medical
Essential Medical, Inc., is a privately held company focused both on evolving the small bore 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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