Subject: TRI
Essential Medical Announces IDE Study Results to be Presented in Late Breaking Clinical Science Session at TVT 2018
MALVERN, Pennsylvania, June 18, 2018 /PRNewswire/ --
Essential Medical, Inc., a private medical device company focused on innovative solutions for large bore vascular closure, today announced that the results from the SAFE MANTA IDE clinical trial will be presented at the Transcatheter Valve Therapies (TVT) 2018 congress in Chicago June 20-22.
Essential Medical's MANTAtm system is the only commercially available vascular closure device specifically designed for large bore femoral artery closure following percutaneous transcatheter interventions outside the U.S. With simple deployment of its resorbable collagen material, a single MANTA device is designed to achieve fast, reliable closure with rapid hemostasis in femoral access sites ranging from 10F to 25F.
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), 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 time 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.
"Data from this IDE study demonstrates MANTA's clinical efficacy to safely close large bore femoral access sites," stated, Professor David Wood, MD, Co-Principal Investigator of the SAFE MANTA trial and co-founding member of the Centre for Heart Valve Innovation in Vancouver, Canada. "MANTA is easy-to-use and has proven to successfully perform reliably across a range of cardiac interventions and puncture sizes within its indicated large bore range."
Dr. Wood will present the results from the MANTA US IDE trial in the Late-Breaking Clinical Science forum in the Main Arena. The presentation will be on Friday, June 22 at 2:45pm in the Sheraton Chicago Ballroom IV-VIII. Dr. Wood's presentation entitled "Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device: The SAFE MANTA", will reveal the results of MANTA use in 341 patients.
Dr. Wood will also present "Upcoming Closure Device System Dedicated to Large Bore Procedures" at 1:02pm on Friday June 22.
Dr. Nicolas Van Mieghem, MD, PhD, Medical Director of the Department of Interventional Cardiology at Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands and Principal Investigator of the European MANTA Registry Trial, MARVEL will present an update on MANTA use in Europe. The presentation entitled 'Large-Hole Trans-femoral Closure III: The MANTA Device' will be on Thursday June 21, at 10:47am as part of the TVT New Technology Forum in the Sheraton Ballroom II-III.
"Essential Medical is thrilled with the results of our SAFE MANTA trial and we look forward to sharing our latest clinical results at TVT," stated Greg Walters, President, CEO and Co-Founder of Essential Medical. "MANTA's proven design, with its resorbable collage and toggle, delivers a simple solution for successful large bore closure."
On Friday, June 22 at 12pm, Essential Medical, Inc. is also supporting the Lunch Satellite Program: Optimization of vessel access and closure in large bore catheter procedure tips and tricks case-based review.
Currently an investigational device only in the U.S. and Canada, MANTA is CE marked and available for sale in 14 countries throughout Central and Northern Europe with continued expansion through the rest of Europe ongoing.
About Essential Medical
Essential Medical is a privately held medical device company dedicated to improving patient outcomes with their large bore closure device that achieves fast, reliable closure with rapid hemostasis for cardiovascular procedures requiring percutaneous transcatheter interventions. By fulfilling the unmet need for simple yet effective large bore closure, Essential Medical is mastering closure to support and enable growth of the fastest growing interventional segments within the cardiology market.
Media contact:
Greg Walters
Essential Medical
[email protected]
+1-(610)-557-1009
SOURCE Essential Medical, Inc.
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