MALVERN, Pennsylvania, May 6, 2015 /PRNewswire/ --
Essential Medical, Inc., a privately held medical device company, announced today that it has successfully completed additional clinical studies using its MANTA 14F Large Bore Vascular Closure device, a revolutionary vascular closure device designed to seal both 14F and 18F large bore femoral punctures.
MANTA 14F devices were successfully deployed in 4 patients, achieving immediate or rapid hemostasis following 14F balloon aortic valvuloplasty cases with excellent clinical, angiographic and hemodynamic (Duplex Ultrasound) results. All patients were successfully discharged the following day. The MANTA devices were deployed in less than one minute, without pain or discomfort for the patients.
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 utilizes novel closure mechanics and can be deployed in less than 60 seconds with 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, Essential Medical CMO, commented on this most recent experience; "The deployment of the devices was excellent. This (study) provides critical information on the application and utility of these valuable additions to the interventional cardiologists toolkit."
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 address all the aforementioned problems. "This series, together with our successful patients with MANTA 18F last November, provides the necessary confidence to proceed to a EU CE-marking study including both MANTA sizes," commented Greg Walters, CEO. "We expect to enroll patients early this summer at sites in Vancouver, Rotterdam, Amsterdam and Milan."
In other recent news, the Company has enrolled the first patients in a post-market study (PMFU) in Germany utilizing its X-Seal small-bore closure devices. The Company is conducting a 50-patient PMFU study as a requirement for X-Seal CE Mark approval that was received in October 2014. Commercialization of X-Seal is expected through a strategic partner once the PMFU study is complete.
About Essential Medical
Essential Medical is a privately held medical device company focused on developing advanced vascular closure technologies 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.
SOURCE Essential Medical, Inc.