IRVINE, Calif.--(BUSINESS WIRE)--Reverse Medical Corporation announced today that it has received CE Mark (Conformité Européenne) for its ReStore™ Microcatheter, intended to restore blood flow in the neurovasculature in patients experiencing ischemic stroke. The CE Mark allows the Company to market the ReStore™ Microcatheter in the European Union and other countries that recognize the CE Mark for commercial distribution purposes.
Commenting on this regulatory approval, Reverse Medical’s Chief Executive Officer Jeffrey Valko said, “The Reverse Medical ReStore™ Microcatheter offers the physician three progressive therapeutic options from one device, aimed to optimize acute ischemic stroke patient outcomes: 1) rapid blood flow restoration, 2) direct infusion into the clot, and 3) neurothrombectomy. With this regulatory clearance for European marketing, initial clinical use will be closely managed to collect data demonstrating superior clinical value compared to competitive products prior to broad commercialization efforts. The Company expects to commence commercialization in early 2010.”
Reverse Medical clinical investigator Prof. Dr. Wolfgang Reith, Director of the Department of Diagnostic and Interventional Neuroradiology at the Saarland University Hospital, Homburg, Germany, stated, “The Reverse Medical ReStore™ Microcatheter offers me several progressive therapeutic options from a single device to improve the odds for favorable acute stroke patient outcomes. This innovative device represents a significant next generation technology from what I’ve used in the past.”
Reverse Medical Corporation is a privately-held medical device company located in Irvine, California. The Company is focused on developing innovative neurovascular devices for improving the treatment of acute stroke patients, and for preventing acute stroke during carotid artery stenting procedures. The Company is working to expand their technology platform to include innovative and state-of-the-art treatments for a broad spectrum of neurovascular disorders and carotid artery disease.
