Novel MANTA device for large bore vascular closure now available in US trial to improve outcomes of percutaneous procedures with sheaths >10F

8 July 2016

Essential Medical Inc. announces FDA approval to begin a U.S. clinical trial in patients undergoing percutaneous procedures using sheaths ranging from 10F to 24F

Novel MANTA device for large bore vascular closure now available in US trial to improve outcomes of percutaneous procedures with sheaths >10F
Essential Medical, Inc., a privately held medical device company addressing the rapidly growing large bore vascular closure market, announced today that it has received Investigational Device Exemption (IDE) approval from the FDA to begin the U.S. clinical trial for MANTA, the company’s Large Bore Vascular Closure Device.  

The pivotal study will evaluate the safety and efficacy of vascular access closure using MANTA for femoral arterial access sites in patients undergoing percutaneous procedures using sheaths ranging from 10F to 24F. MANTA will be used to achieve safe, percutaneous closure in a variety of large bore procedures including transfemoral transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAA), ventricular assist devices (VAD), and balloon aortic valvuloplasty (BAV).  

These large bore procedures are the fastest growing segment of the cardiovascular market and are driving a worldwide market for large bore vascular closure devices to exceed $600 million within the next 5 years. Closure of large bore femoral access sites has been associated with significant increases in morbidity including longer times to achieve hemostasis, extended procedure time, higher rate of complications, and higher total cost of care. 

MANTA was specifically designed to address these complexities of closing large punctures in high pressure vessels utilizing novel closure technology. MANTA’s simple and fail-safe deployment provides immediate hemostasis in order to reduce the complications and cost associated with large bore closure.

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