Essential Medical, Inc., a privately held medical device company addressing the vascular closure market, announced 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, says, “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.