EXTON, Pennsylvania, January 8, 2018 /PRNewswire/ --
Essential Medical, Inc. today announced the completion of the 60-day follow up for the MANTA™ U.S. Pivotal Study.
Dr. Gary Roubin, Chief Medical Officer of the company, stated, "We're adding to the growing pool of data with the longer term 60-day follow up for the MANTA device. The data from this study of 341 patients along with our over 3000 commercial cases in parts of Europe continues to provide us with great confidence in the clinical benefits of the MANTA device. Our team is on track to submit our PMA to the FDA in the next 90 days as we continue to make great progress towards enabling safer and more effective large bore closure in the US."
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, Sweden, Denmark, and Iceland.
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.
Contact Greg Walters, [email protected], http://www.essmedclosure.com
SOURCE Essential Medical, Inc.
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Essential Medical, Inc. today announced the completion of the 60-day follow up for the MANTA™ U.S. Pivotal Study.
Dr. Gary Roubin, Chief Medical Officer of the company, stated, "We're adding to the growing pool of data with the longer term 60-day follow up for the MANTA device. The data from this study of 341 patients along with our over 3000 commercial cases in parts of Europe continues to provide us with great confidence in the clinical benefits of the MANTA device. Our team is on track to submit our PMA to the FDA in the next 90 days as we continue to make great progress towards enabling safer and more effective large bore closure in the US."
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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, Sweden, Denmark, and Iceland.
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.
Contact Greg Walters, [email protected], http://www.essmedclosure.com
SOURCE Essential Medical, Inc.
