CTO Guidewire System Receives FDA Clearance

Ovalum Ltd., a privately held Israeli medical device company, has received FDA marketing clearance for the CiTop Guidewire system for angiographic procedures in the peripheral vasculature, a device intended to assist in the treatment of chronic complete arterial blockage (CTO).

The CiTop Guidewire system was studied in a randomized multinational study with results demonstrating the safety and effectiveness of the device in treating Peripheral Artery Disease (PAD) patients with chronic total occlusions. The results reportedly demonstrated that the CiTop Guidewire system successfully crossed occlusions that other guidewires failed to cross.