Essential Medical, Inc., a privately held medical device company addressing the rapidly growing large bore vascular closure market, announced that it has submitted their CE Mark application for MANTA, the company's large bore vascular closure device.
The single arm, 50 patient study shows conclusively that MANTA successfully achieves immediate hemostasis (median TTH was 24 seconds) in the femoral arterial access site in patients undergoing percutaneous large bore procedures using sheaths ranging from 14F to 24F. With immediate hemostasis, and a device deployment time of 1-2 minutes, operators say they are seeing 20-30 minutes or greater savings in total procedure time when compared to suture mediated closure devices. There were zero (0 per cent) minor and one (2 per cent) major device related complications based on the VARC-2 definitions.
Clinical results have been presented at the JIM conference in Milan by the principal investigator Nicolas Van Mieghem, MD, PhD, medical director of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands "The use of MANTA in our cathlab reduced our TAVR procedure time and made percutaneous closure of large bore arteriotomies in general more predictable. We are very excited about the pending CE Mark and are excited to start using MANTA in our daily practice!"
Dr. Gary Roubin, MD, PhD, Essential Medical's chief medical officer, commented "With the full data set now assembled, the MANTA device has demonstrated superlative clinical results and we expect BSI to approve our CE Mark application early this summer."
MANTA is a novel 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), ventricular assist (VAD), and balloon aortic valvuloplasty (BAV). 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. 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 utilising novel closure technology. MANTA's fail-safe deployment provides immediate hemostasis in order to reduce complications associated with large bore closure.