Reverse Medical (Irvine, California) said the FDA has approved its investigational device exemption to study its Barrel vascular reconstruction device (VRD). The Barrel VRD is designed for use with occlusive devices in the treatment of intracranial bifurcation aneurysms.
According to J Mocco, MD, an associate professor of neurology surgery, radiology and radiological sciences, at Vanderbilt University Medical Center (Nashville, Tennessee), the Barrel VRD represents "a simple, elegant solution for challenging anatomy that physicians are often faced with." Mocco will serve as the principal investigator for the trial.
Jeffrey Valco, president/CEO of Reverse Medical, said the company plans to finalize the clinical trial infrastructure "very soon" and begin patient enrollment within the next few months.
"The Barrel design is unique, essentially reducing the neck size of wide-neck bifurcation aneurysms, enabling traditional coil embolization, a craft already mastered by the neuro interventionalist," Valco said.
Reverse Medical is a private company with a technology pipeline aimed at endosvascular treatments for peripheral and neurovascular disorders and diseases.
In February, the company reported the initial clinical use of its UNO neurovascular embolization system for intracranial use (Medical Device Daily, Feb. 19, 2014). The device was granted CE mark approval to obstruct blood flow in the neurovasculature.
In December, the company reported getting FDA 510(k) clearance to sell its MVP-5 micro vascular plug system for peripheral vessel embolization in the U.S. (MDD, Dec. 12, 2013). The MVP-5 is indicated for use to obstruct or reduce the rate of blood flow in the peripheral vasculature, in vessels measuring between 3 and 5 millimeters.