European Studies Begin for Essential Medical's Manta Large-Bore Vascular Closure Device

July 27, 2015—Essential Medical, Inc. announced that it has commenced European clinical studies using its Manta large-bore vascular closure device, which is designed to seal both 14-F and 18-F large-bore femoral punctures. The Manta device closes femoral arterial punctures made during cardiac catheterization procedures such as transcatheter aortic valve replacement, endovascular treatment of abdominal aortic aneurysms, ventricular assist, and balloon aortic valvuloplasty. The Manta was designed to address the complexities of closing large holes in high-pressure vessels. The 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.

According to the company, Nicholas Van Mieghem, MD, and Antonio Colombo, MD, enrolled the initial patients in the study. Dr. Van Mieghem is Medical Director of the Department of Interventional Cardiology at the Thoraxcenter of Erasmus Medical Center in Rotterdam, The Netherlands. Dr. Colombo is Director of the Invasive Cardiology Department at San Raffaele Scientific Institute and Columbus Hospital in Milan, Italy.

Essential Medical reported that the Manta 18-F devices were successfully deployed, achieving immediate hemostasis after transcatheter aortic valve replacement with excellent clinical, angiographic, and hemodynamic (duplex ultrasound) results. The Manta devices were deployed in less than 1 minute, without pain or discomfort for the patients, and no patients experienced any complications associated with the device.

On the enrollment experience, Gary Roubin, MD, Essential Medical’s CMO, stated, “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.”

Dr. Van Mieghem commented that the Manta device “is a revolutionary device that will transform how we close cases.” Dr. Colombo stated that the device “is a nice step [toward] making large-bore closure a simple and reliable procedure.”

As noted by the company, closure of large-bore femoral access sites has been associated with significant morbidity, including long times to achieve hemostasis, extended operating room time, need for a vascular surgeon in the catheterization lab, delayed ambulation, higher rates of complications, and higher total cost of care.

Essential Medical also announced that 23 patients have been enrolled in a postmarket follow-up study in Germany utilizing the company’s X-Seal small-bore closure device. The study, which will enroll 50 patients, is being conducted as a requirement for European CE Mark approval of the X-Seal. When the postmarket study is completed, the company will commercialize the X-Seal through a strategic partner.