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February 17, 2014
Reverse Medical's Uno Neurovascular Embolization System Approved in Europe for Intracranial Use
February 18, 2014—Reverse Medical Corporation (Irvine, CA) announced the CE Mark approval and initial clinical use of the Uno neurovascular embolization system for intracranial use. The device is approved in the European Union to obstruct blood flow in the neurovasculature. The company will begin commercialization in Europe this year through a network of expert regional distributors.
According to the company, the Uno system has demonstrated immediate vessel occlusion upon target deployment from a rapidly delivered single implant. The Uno device is designed to provide microcatheter deliverability, 100% resheathability, and superselective positioning.
Reverse Medical advised that Professor Marco Leonardi, MD, of the University of Bologna in Italy, performed the initial clinical case with the Uno system.
In the company’s press release, Prof. Leonardi commented, “The Uno represents a unique device, specifically designed for rapid vessel sacrifice, reducing the time otherwise necessary for multiple coil deployments. I can see the Uno becoming a useful tool in my practice. Microcatheter deliverability is excellent within tortuous anatomy, and resheathability offers me confidence of placement accuracy.”
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