Reverse Medical Corporation Announces Regulatory Approvals for Its Microcatheters for Neurovascular Indications
Reverse Medical Corporation today announced CE Mark approval, FDA 510k clearance and initial clinical use of their ReVerse® Microcatheter product line for intracranial neurovascular use. The device has been granted European Union CE Mark approval and US FDA 510k clearance for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils. This new microcatheter line also provides physicians with a steam shapeable tip option.
Stanley L. Barnwell, MD PhD, Medical Director, Interventional Neuroradiology, Oregon Health and Sciences University (Portland, OR), performed the initial clinical case with the ReVerse 27 Microcatheter and commented, “I was impressed with the performance of this microcatheter – it provided smooth and stable delivery of the flow diverter device in distal anatomy.” Reverse Medical Chief Technology Officer Brian Strauss commented, “Building on our expertise and proprietary know-how from our intracranial distal access catheter success, we identified an unmet need for a microcatheter designed specifically for delivery of new, complex therapeutic devices. The ReVerse Microcatheter incorporates proprietary inner lumen friction reducing and strengthening technology and is designed to facilitate predictable, low friction state-of-the-art device delivery.” The ReVerse Microcatheter is available in 0.021” and 0.027” inner lumen diameters and will be supported by a direct US Sales force and a network of expert regional worldwide distributors.
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 disease. The company is based in Irvine, California.