MALVERN, Pa., Nov. 17, 2014 /PRNewswire/ -- Essential Medical, Inc., a privately held medical device company, announced today that it has successfully completed First in Man studies for its MANTA Large Bore Vascular Closure device, a revolutionary vascular closure device designed to seal 18F large bore femoral punctures.
18F MANTA devices were safely and effectively deployed in 5 patients in this initial series, achieving immediate or rapid hemostasis at the large bore puncture site with excellent clinical, angiographic and hemodynamic (Duplex) success in all patients. Patients were discharged the following day. There was no evidence of hematoma in any patient. The MANTA devices were deployed in less than one minute in each patient.
MANTA closes femoral arterial punctures made during cardiac catheterization procedures such as transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), and the endovascular treatment of abdominal aortic aneurysms (AAA). MANTA can be deployed in less than 60 seconds and utilizes sealing components similar to the Company's other closure device, X-Seal. The potential worldwide market for vascular closure products is approximately $1 billion.
Dr. Gary Roubin, MD, PhD, a world-renowned interventional cardiologist, performed the first two cases and commented, "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."
Dr. Lawrence Garcia, Chief of Interventional Cardiology, St. Elizabeth's Medical Center in Boston and internationally recognized as a thought leader in peripheral vascular interventions who also participated in the study stated, "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."
Large bore femoral access has been associated with significant morbidity including bleeding complications, the need for transfusions, increased hospital costs, patient discomfort and disability. The MANTA device has the potential to solve all the aforementioned problems. "Our team is thrilled to bring forward a device technology that can manage challenging 14F and 18F closures," commented Greg Walters, CEO. "We look forward to initiating a CE-marking study in early 2015."
About Essential Medical
Essential Medical is a privately held medical device company aiming to develop and commercialize new vascular closure devices for femoral punctures after diagnostic and interventional cardiac catheterization procedures. The company was founded in 2010 by Greg Walters, a senior product development executive with 20 years' experience creating innovative cardiovascular products, and Dr. Gary Roubin, MD, PhD, a coronary and carotid stenting pioneer.
Contact: Greg Walters, [email protected]
SOURCE Essential Medical, Inc.