Essential Medical receives FDA approval for X-Seal 6F vascular closure device clinical trial


Essential Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin the US clinical trial of 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 USA, Canada, and the EU. The safety and efficacy of the X-Seal device will be evaluated through a comparison of measured complication rate, time to haemostasis, and time to ambulation against a performance goal.

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.