Reverse Medical Receives FDA Approval for Vascular Reconstruction Device

Reverse Medical Corporation has received U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) approval for the clinical investigation of its Barrel Vascular Reconstruction Device (VRD). The product is designed to be used 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,” said J. Mocco, M.D., M.S., associate professor of Neurological Surgery, Radiology and Radiological Sciences at Vanderbilt University Medical Center. “FDA approval of this clinical trial represents a significant accomplishment, and we’re excited to begin evaluating this  endovascular treatment alternative for patients with limited options available today. I look forward to collaborating with my colleagues on the trial.”

The company won CE Mark approval for its Barrel vascular reconstruction device last year. The product is intended for use with embolic coils for the treatment of wide-neck bifurcating or branch intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm, measured by 2D Digital Subtraction Angiography. Wide-neck is defined as having a neck width ≥ 4 mm or a dome-to-neck ratio < 2.

“The Barrel VRD represents our commitment as a neuro endovascular technology company,” noted Reverse Medical CEO Jeffrey Valko. “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 essentially reduces the neck size of wide-neck bifurcation aneurysms, enabling traditiional coil embolization, a craft already mastered by the Neuro Interventionalist.”

Based in Irvine, Calif., Reverse Medical develops endovascular treatments for various peripheral and neurovascular disorders and diseases.