FDA IDE Approval for BARREL® Intracranial Bifurcation Aneurysm Solution

Reverse Medical® Corporation has gained FDA IDE approval for clinical investigation of its BARREL® Vascular Reconstruction Device (VRD). The BARREL® Vascular Reconstruction Device is designed for use with occlusive devices in the treatment of intracranial bifurcation aneurysms.

Background

Reverse Medical’s Barrel is described as a stent assisted endovascular treatment for addressing wide-necked bifurcation aneurysms. Able to support an embolic coil, the device is easily delivered through a microcatheter with excellent fluoroscopic visualisation of the device including the barrel segment. In an earlier study, in all cases the device was easy to position with good coil mass support and device stability. Furthermore, being resheathable, it could be placed into either the contralateral or ipso-lateral vessel of the bifurcation aneurysm, depending on which vessel position offered the best neck coverage and it could be manipulated in situ to further gain optimal neck coverage.

1, 2, 3 and 6-month angiographic follow-ups have previously confirmed that the device continued to provide both coil mass stability and neck coverage and histological examination at 3 months demonstrated zero or minimal vessel wall damage, with mature, stable and endothelialised neointima at aneurysmal necks.

Nicely set-up then for this new IDE study that may pave the way for U.S. approval.

Physician comments

“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.”

Company comments

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.”

Source: Reverse Medical, Inc., Business Wire, Journal of Neuro-Interventional Surgery

 

 

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