FDA IDE Approval for the BARREL Vascular Reconstruction Device for Treatment of Aneurysms
Reverse Medical Corporation today announced FDA IDE approval for clinical investigation of their BARREL Vascular Reconstruction Device (VRD). The BARREL Vascular Reconstruction Device is designed for use with occlusive devices in the treatment of intracranial bifurcation aneurysms.
“The BARREL VRD device represents a simple, elegant solution for challenging anatomy that physicians are often faced with,” stated J Mocco, MD, MS, Associate Professor of Neurological Surgery, Radiology and Radiological Sciences, Vanderbilt University Medical Center. “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.” Reverse Medical President and CEO Jeffrey Valko commented, “The BARREL VRD represents our ongoing commitment as a neuro endovascular technology innovation company. The Reverse Medical team worked closely with FDA to achieve this milestone, with our near-term goal now behind us. We plan to finalize the BARREL VRD 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.”