First-in-Man Studies Completed for Essential Medical's 18-F Manta Large-Bore Vascular Closure Device

November 17, 2014—Essential Medical, Inc. announced that it has completed first-in-man studies for the Manta large-bore vascular closure device, which is designed to seal 18-F, large-bore femoral punctures. 

The company advised that 18-F Manta devices were safely and effectively deployed in five patients in this initial series, achieving immediate or rapid hemostasis at the large-bore puncture site with excellent clinical, angiographic, and hemodynamic success in all patients. The Manta devices were deployed in < 1 minute in each patient. The patients were discharged the next day, and there was no evidence of hematoma in any patients.

According to Essential Medical, the Manta device closes femoral arterial punctures made during cardiac catheterization procedures such as transcatheter aortic valve replacement, balloon aortic valvuloplasty, and the endovascular treatment of abdominal aortic aneurysms. The Manta device is intended to address the problems associated with large-bore femoral access, including bleeding complications, the need for transfusions, increased hospital costs, and patient discomfort and disability.

The Manta, which can be deployed in < 60 seconds, uses sealing components similar to the company's other closure device, X-Seal. Essential Medical recently announced that it has received European CE Mark approval for the X-Seal vascular closure device.

Gary Roubin, MD, who performed the first two cases with the Manta device, is cofounder of Essential Medical. Dr. Roubin commented in the company’s press release, “In interventional cardiology it’s critical to define the problem that the patient is facing, solve the problem, and use the best clinical science available to confirm beneficial outcomes. We're doing that with Manta, and it promises to be a truly transformative technology for providing percutaneous access for large-bore therapeutic devices.”

Lawrence Garcia, MD, who participated in the study, added, “This device fills a critical unmet need for endovascular procedures in being able to quickly and reliably close large-bore catheter channels. This ability, done simply and safely, is a major step to full percutaneous procedures in both the cardiac and peripheral markets.”