Essential Medical said today it won an Investigational Device Exemption from the FDA to begin a trial of its X-Seal 6F vascular closure device.
The 180-patient pivotal study will run across 10-16 sites in the U.S., Canada and the European Union, Malvern, Penn.-baed Essential Medical said.
“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,” chief medical officer Dr. Gary Roubin said in a press release.
The trial will examine the safety and efficacy of the X-Seal device through the comparison of complication rates, time-to-hemostasis and time-to ambulation rates, the company said.
Essential Medical said it already received CE Mark approval in the EU and completed a post-market study of the device in February.
Last month, Essential Medical said it won CE Mark approval in the European Union for its Manta vascular closure device.
The device is designed to close punctures in less than 1 minute, providing immediate hemostasis, using absorbable biomaterials in an “anchor/plug” sealing technology, according to Essential Medical’s website.