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Noticias
IRVINE, Calif.--(BUSINESS WIRE)--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.”
Reverse Medical Corporation is a privately held medical device company focused on expanding a technology driven pipeline of innovative, state-of-the-art endovascular treatments for a broad spectrum of peripheral and neurovascular disorders and diseases. The company is based in Irvine, California.
Contacts
Reverse Medical Corporation
Jeffrey Valko, President & CEO
949-215-0660, ext. 201