Essential Medical Inc. Announces FDA Approval to Begin a U.S. Clinical Trial for the X-Seal 6F Vascular Closure Device

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 inFebruary 2016 with excellent results. This X-Seal IDE Approval compliments the IDE Approval recently secured for company's MANTA Large Bore Closure Device.

Source: Essential Medical, Inc.