Reverse Medical has obtained the US Food and Drug Administration (FDA) IDE approval for clinical investigation of its Barrel vascular reconstruction device (VRD).
The Barrel VRD is designed to be used with occlusive devices when treating intracranial bifurcation aneurysms.
Vanderbilt University Medical Center associate professor of neurological surgery, radiology and radiological sciences Dr J Mocco said 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," Dr Mocco added.
"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 said the Barrel VRD represents company’s 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," Valko added.
"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."
Earlier in December 2013, Reverse Medical received CE Mark approval in the European Union for its Barrel VRD for treating intracranial aneurysms.