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April 14, 2014
Reverse Medical to Study Barrel VRD to Treat Intracranial Bifurcation Aneurysms
April 15, 2014—Reverse Medical Corporation (Irvine, CA) announced that the US Food and Drug Administration approved an investigational device exemption for a clinical study of the company’s Barrel vascular reconstruction device (VRD). The company advised that it will soon finalize the infrastructure for the Barrel VRD clinical trial and begin patient enrollment within the next few months.
The Barrel VRD is designed for use with occlusive devices in treating intracranial bifurcation aneurysms. The device reduces the neck size of wide-neck bifurcation aneurysms to enable traditional coil embolization, stated the company.
In Reverse Medical’s press release, the trial’s Principal Investigator J Mocco, MD, commented, “The Barrel VRD device represents a simple, elegant solution for challenging anatomy that physicians are often faced with. FDA approval of this clinical trial represents a significant accomplishment, and we’re excited to begin evaluating this promising endovascular treatment alternative for patients with limited options available today. I’m honored to serve as principal investigator, and I look forward to collaborating with my colleagues on the trial.” Dr. Mocco is Associate Professor of Neurological Surgery, Radiology, and Radiological Sciences at Vanderbilt University Medical Center in Nashville, Tennessee.
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