MALVERN, Pennsylvania, December 12, 2016 /PRNewswire/ --
Essential Medical, Inc., a privately held medical device company addressing the rapidly growing $600M large bore vascular closure market, announced today the start of the MANTA Vascular Closure Device U.S. Pivotal Trial.
The first U.S. case was performed on November 28 by Dr. Itsik Ben-Dor, MD at the Washington Hospital Center in Washington D.C. After successfully implanting a 34mm Medtronic CoreValve Evolut R, the 21F arteriotomy was closed with the 18F MANTA device, which provided immediate hemostasis and a clear patent vessel.
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, was on site for the case and stated, "The team in Washington did a great job implanting the first 18F MANTA closure device in North America. The result was excellent and we are keen to start enrolling patients in the trial. This technology has the potential to be a real game changer for transfemoral TAVR."
The second TAVR patient was enrolled at Texas Heart in Houston, Texas. Dr. Zvonko Krajcer, Co-Principal Investigator of the MANTA trial and Co-Director of the Peripheral Vascular Disease Service at Texas Heart performed this procedure. He successfully closed a 23F arteriotomy with the 18F MANTA and achieved immediate hemostasis.
After the first two implantations in North America, Dr. Krajcer led efforts in the first MANTA closure following an EVAR procedure. The successful EVAR was performed using an Ovation iX stent graft, creating a 14F arteriotomy closed with the 14F MANTA. Hemostasis was achieved in under 30 seconds.
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). The MANTA is currently available for sale in the Netherlands.
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.
SOURCE Essential Medical Inc