Essential Medical has received investigational device exemption (IDE) approval from the FDA to begin the US 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 US, Canada, and the EU. Safety and efficacy of the X-Seal device will be evaluated through comparison of measured complication rate, time-to-haemostasis, and time-to-ambulation against a performance goal.
Gary Roubin, chief medical officer of the company, states, “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.