US-based medical device company Essential Medical has secured investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate the clinical trial of its X-Seal 6F Vascular Closure Device.
X-Seal is used as a femoral artery closure device to close femoral punctures after vascular access medical procedures which required cardiac catheterisation.
The single-arm, pivotal trial will be conducted across 10 to 15 sites across the US, Canada, and the EU and will enroll around 180 patients.
The trial is designed to evaluate the safety and efficacy of the X-Seal device by comparing its performance on the basis of measured complication rate, time-to-hemostasis, and time-to-ambulation against a performance goal.
Essential Medical chief medical officer Dr Gary Roubin 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."
X-Seal is designed to close small bore arterial punctures measuring 6F- 8F following commonly used procedures such as angiography, angioplasty, and stenting, which are largely used for patients treated via arterial catheterisation.
The operation mechanism of the X-Seal device is based on anchor / plug sealing technologies using common absorbable biomaterials and is equipped with x-ray visibility and improved deployment control.