MALVERN, Pennsylvania, August 1, 2016 /PRNewswire/ --
Essential Medical, Inc., a privately held medical device company addressing the vascular closure market, announced today that it has received Investigational Device Exemption (IDE) approval from the FDA to begin the U.S. clinical trial for X-Seal, the company's 6F Vascular Closure Device.
The single-arm, pivotal study will consist of 180 patients at 10-15 sites throughout the U.S., Canada, and the EU. Safety and efficacy of the X-Seal device will be evaluated through comparison of measured complication rate, Time-to-Hemostasis, and Time-to-Ambulation against a performance goal.
Dr. Gary Roubin, Chief Medical Officer of the company, stated, "The X-Seal device provides a necessary improvement to current closure devices. Combining proven technology with novel deployment control features, the X-Seal device allows for consistent closure performance. I am pleased that the device is one step closer to US commercial availability."
The X-Seal 6F Vascular Closure Device is already CE-marked with a Post-Market study completed in the EU in February 2016 with excellent results. This X-Seal IDE Approval compliments the IDE Approval recently secured for company's MANTA Large Bore Closure Device.
About Essential Medical
Essential Medical, Inc., is a privately held company focused both on evolving the small bore market and transforming the large bore vascular closure market by delivering products that meet the unmet need for fast closure without complications. 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.