Essential Medical Inc. Announces Successful Commencement of EU Studies for MANTA™ Large Bore Vascular Closure Device

Essential Medical, Inc., a privately held medical device company focused on transforming the large bore vascular closure market, announced today that it has successfully commenced EU clinical studies using its MANTA Large Bore Vascular Closure device, a novel vascular closure device designed to seal both 14F and 18F large bore femoral punctures.  

Initial patients in the study were enrolled in Rotterdam and Milan where MANTA 18F devices were successfully deployed achieving immediate hemostasis following transcatheter aortic valve replacement (TAVR) with excellent clinical, angiographic and hemodynamic (Duplex Ultrasound) results. The MANTA devices were deployed in less than one minute, without pain or discomfort for the patients. None of the patients experienced any complications associated with the device.  

MANTA closes femoral arterial punctures made during 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 but the growth is limited by the lack of a safe and reliable large-bore percutaneous closure device. MANTA was purposely designed to address the complexities of closing large holes in high-pressure vessels utilizing novel closure technology. MANTA's fail-safe deployment closes large punctures in less than 60 seconds, providing immediate hemostasis in order to reduce complications associated with large bore closure. The potential worldwide market for large bore vascular closure device exceeds $650 million.

Cases were conducted by Nicholas Van Mieghem, MD, PhD, Medical Director of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center, who commented that MANTA, "is a revolutionary device that will transform how we close cases," and Antonio Colombo, MD, Director of the Invasive Cardiology Department at San Raffaele Scientific Institute and Columbus Hospital, who commented that the MANTA device "is a nice step [toward] making large bore closure a simple and reliable procedure."

Closure of large bore femoral access sites has been associated with significant morbidity including long time to achieve hemostasis, extended OR time, need for a vascular surgeon in the catheterization lab, delayed ambulation, higher rate of complications and higher total cost of care. Dr. Gary Roubin, MD, PhD, Essential Medical CMO, commented on this most recent experience; "The deployment of the devices was flawless, and both clinicians found the MANTA to be intuitive, easy-to-use and efficacious. Including our First-in-man studies, we have now enrolled 19 patients to date with rapid hemostasis and no major complications.  We look forward to enrolling other centers in Hamburg and Vancouver shortly."  

In other recent news, the Company has now enrolled 23 patients to date in a post-market-follow-up study (PMFU) in Germany utilizing its X-Seal™ small-bore closure device. This study is a 50-patient PMFU study as a requirement for X-Seal CE Mark approval. Commercialization of X-Seal is expected through a strategic partner once the PMFU study is completed.

Source: Essential Medical, Inc.