MALVERN, Pennsylvania, January 22, 2016 /PRNewswire/ --
Essential Medical, Inc., a privately held medical device company, announced today that it has completed enrollment in the post-market-follow-up study (PMFU) in Germany utilizing its X-Seal™ small-bore closure device. Preliminary results show Time-To-Hemostasis less than one minute with no major complications, indicating that X-Seal performs on par or better than existing small-bore VCD's. The current estimated worldwide market for vascular closure products is approximately $500 million.
X-Seal is the company's CE Marked 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.
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."
Tobias Graf, MD, Principal Investigator at University Heart Center in Lübeck, Germany, commented "the tension gage within the device is really innovative [and] minimizes risk of device misuse".
X-Seal is CE-marked and commercialization is expected through a strategic partner.
Essential Medical is also pleased to announce that it has recently submitted an Investigational Device Exemption (IDE) application to the U.S. FDA for a U.S. pivotal study of X-Seal.
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.