CE Mark and First Case for Reverse Medical’s UNO™ Neurovascular Embolization System for Intracranial Use

Reverse Medical Corporation, a frequent visitor to our pages, has announced CE Mark and the initial clinical use of the UNO™ Neurovascular Embolization System for intracranial use in obstructing blood flow in the Neurovasculature.

Background

California based Reverse Medical says it is focused on expanding its technology-driven pipeline of innovative, state-of-the-art endovascular treatments for a broad spectrum of peripheral and neurovascular disorders and disease. One such is the UNO embolization device, which, as the name suggests comprises a single-shot, rapidly deployed single implant, achieving accurate targeting for effective vessel occlusion, with the added feature of being fully re-sheathable, which means the operating physician can ensure correct positioning before deployment.

The first clinical case in which UNO was employed took place under Professor Marco Leonardi at Università di Bologna, Italy.

Physician comments

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”.

Company comments

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”.

Source: Reverse Medical, Inc., Business Wire

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