Reverse Medical Receives CE Mark
IRVINE, Calif.--Reverse Medical Corporation
today announced the initial clinical use of their UNO™ Neurovascular Embolization System for intracranial use. The device has been granted European Union CE Mark approval to obstruct blood flow in the Neurovasculature. A CE mark enables a product to be marketed in the EU.
Professor Marco Leonardi at Università di Bologna, Italy performed the initial UNO System clinical case. Professor 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 re-sheathability offers me confidence of placement accuracy”.
Reverse Medical President and CEO Jeffrey Valko, commented, “Tolerable neurovascular vessel sacrifice is often considered as a safe, cost effective alternative to aggressive and often risky vessel salvage. Intracranial vessel sacrifice has routinely involved multiple costly embolization coils and a lengthy procedure, with extensive fluoroscopy radiation exposure to both the patient and the clinical team. The UNO System has demonstrated immediate vessel occlusion upon target deployment from a rapidly delivered single implant, One and Done™! The unique device design features of Microcatheter deliverability, 100% resheathability, and superselective positioning have offered the Neurointerventionalist a new instrument, reaffirming our commitment to Neuro Endovascular innovation. It is always exciting and impressive, to observe technical innovation lead to clinical-use innovation”.
The Company will continue to confirm superior clinical device performance from the UNO System and begin commercialization in Europe this year through a network of expert regional 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.
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Mike Bunker manages the Early Stage Partners investment in Reverse Medical