Reverse Medical secured European CE Mark approval for its UNO neurovascular embolization system, for obstructing blood flow in the blood vessels of the brain. The device also notched initial clinical use for intracranial specification.
The device is a single-shot, rapidly deployed implant designed to target blockages or occlusions. The device is also re-sheathable, meaning that correct positioning can be insured before the device is deployed. Reverse plans to start selling the device throughout Europe later this year through its existing network of distributors, according to the press release.
“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," president and CEO Jeffrey Valko said in prepared remarks. "The UNO System has demonstrated immediate vessel occlusion upon target deployment from a rapidly delivered single implant."
The Irvine, Calif.-based medical device company closed 2013 on a strong note, landing 510(k) clearance for its MVP-5 micro vascular plug. The plug is indicated for the treatment of peripheral vessel embolization, to obstruct or reduce the rate of blood flow in the peripheral vasculature, particularly in vessels measuring between 3.0 and 5.0 mm.
