MALVERN, Pa., Oct. 27, 2014 /PRNewswire/ -- Essential Medical, Inc., a privately held medical device company, announced today that it has received CE mark approval for X-Seal, a new vascular closure device with superior handling and closure features.
X-Seal closes femoral arterial punctures made during cardiac catheterization procedures such as angiograms, angioplasty, and stenting. X-Seal is designed to provide Cath Lab professionals with superior closure and improved hemostasis. The potential worldwide market for vascular closure products is approximately $1 billion.
Gary Roubin, MD, PhD, a world-renowned interventional cardiologist and co-founder of Essential Medical said "X-Seal represents a truly 'next-generation' closure device, offering excellent sealing, angiographic marking, and controlled deployment."
In addition to X-Seal, Essential Medical is developing MANTA, a revolutionary and elegant large bore device for sealing larger femoral arterial punctures made during transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), and the endovascular treatment of abdominal aortic aneurysms (AAA). This large bore device utilizes sealing components similar to X-Seal, and can be easily deployed within 60 seconds. First in man studies are starting soon and a larger EU study is expected to begin in 2015. "We expect our large bore device will provide a closure solution that will improve patient outcomes and reduce the overall cost of the respective procedures with an easy to use product," commented Greg Walters, CEO.
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.