The case was performed live on Monday October 31st by Nicolas Van Mieghem, MD, PhD, Medical Director of the Department of Interventional Cardiology and Professor dr PPT de Jaegere from Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands via satellite feed.
After successfully implanting a 23mm Boston Scientific Lotus valve, the 22F arteriotomy was successfully closed with the 18F MANTA device, which provided immediate hemostasis and a clear patent vessel.
TCT Course Directors moderated the live case streaming from Rotterdam to an audience of approximately 2000 in attendance in Washington DC. After reviewing the angiogram confirming a perfectly sealed and patent vessel, both moderators commented on the impressive results.
Greg Walters, President and CEO of Essential Medical, commented on the live case results, "It was very rewarding for our team to see our MANTA device provide the patient with an excellent outcome and to hear the moderators comment on the impressive result with the MANTA device as a 'game changer'."
Dr. Gary Roubin, Chief Medical Officer of the company, stated, "We are pleased with the outcome in this live demonstration case as it reflects the clinical results observed in the European Study. The Manta System will enable safer and more effective large bore closure with faster ambulation and discharge. Importantly, the case demonstration highlighted the ease of use of the device. We know that access site complications continue to limit the advancement of large bore procedures because vascular closure technology has not kept pace with valve and stenting technologies. This is no longer the case with MANTA."
The MANTA live case may be viewed with a tctmd.com membership or attendance at the conference.
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). An IDE study is underway in the US.
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.
Contact: Greg Walters, email@example.com , http://www.essmedclosure.com, +1-610-633-3136
SOURCE Essential Medical, Inc.