Essential Medical announced 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."
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.