Reverse Medical's ReFlex A+ Catheter receives European CE mark approval

Reverse Medical Corporation announced today that it has received CE Mark (Conformité Européenne) for its ReFlex™ A+ Catheter for intracranial distal access, delivery and aspiration. The ReFlex A+ Catheter is uniquely designed to provide endovascular intracranial access during interventional neurovascular procedures. The CE Mark allows the Company to market ReFlex™ A+ Catheter in the European Union and other countries that recognize the CE Mark for commercial distribution purposes.

The ReFlex™ A+ Catheter provides the neurovascular specialist with a line of advanced access devices that can navigate into complex neurovascular anatomy, which may enable them to treat more patients than with currently available devices.

Reverse Medical clinical advisor Dr. Vitor Mendes Pereira MD MSc, Neurointerventional Unit, University Hospital of Geneva Switzerland stated, "From my initial clinical experience, the ReFlex offered superior performance in terms of flexibility for distal navigation, support, kink resistance and aspiration. The larger internal lumen allows me to inject contrast during dual Microcatheter manipulations, clearly visualizing the target anatomy. The ReFlex A+ Catheter will be useful in cases where accurate positioning is critical, such as during stent or aneurysm flow diverter implantation. The distal navigation and larger lumen size of the ReFlex enabled more effective aspiration, which should optimize acute stroke treatment."

Commenting on this regulatory approval, Reverse Medical's President and Chief Executive Officer, Jeffrey Valko said, "Intracranial endovascular access continues to expand the market for treating all neurovascular disorders. The ReFlex A+ Catheter design embodies proprietary and unique design features for greater flexibility, microcatheter support, and kink resistance, with the largest internal diameter of any commercially available neurovascular access catheter. These features are particularly important for enabling a wide range of dual microcatheter support without diminishing contrast infusion, and providing a platform for focal thrombi aspiration, minimizing distal emboli during thrombectomy in acute ischemic stroke patients. We believe the ReFlex A+ Catheter line of devices will allow physicians to expand their therapeutic options for treating previously under-served patient populations." The ReFlex A+ Catheter is approved for 4, 5 and 6 French sizes, with straight and multi purpose curve tip configurations. The Company plans to immediately commence European and Asian commercialization through prominent international distributors, in territories that recognize the CE Mark.