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August 3, 2016
Essential Medical Set to Begin Pivotal X-Seal 6-F Closure Device Study
August 4, 2016—Essential Medical, Inc. has received investigational device exemption approval from the US Food and Drug Administration to begin the United States clinical trial for X-Seal, the company's 6-F vascular closure device.
According to Essential Medical, the single-arm pivotal study will consist of 180 patients at 10 to 15 sites throughout the United States, Canada, and the European Union. 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.
The X-Seal 6-F vascular closure device has received European CE Mark approval. A postmarket study in the European Union was completed in February 2016 with excellent results, stated the company.
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