Vascular technology company, Essential Medical, Inc., says 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.
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. Indeed, procedures including transcatheter aortic valve replacement (TAVR), endovascular treatment of abdominal aortic aneurysms (AAA), ventricular assist (VAD), and balloon aortic valvuloplasty (BAV) are the fastest growing segment of the cardiovascular market, with growth limited by the lack of a safe and reliable large-bore percutaneous closure device.
Essential Medical’s MANTA closes femoral arterial punctures made during these cardiac catheterization procedures. 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, according to the company.
Initial patients in the new 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.
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.”
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.”
Source: PR Newswire