The device, which tunnels into blockages in limb arteries, has EU CE Mark approval.
Medical device start-upOvalum Ltd. has obtained US Food and Drug Administration (FDA) marketing approval for its CiTop Guidewire for the peripheral vasculature applications. The company obtained EU CE Mark approval for the device last month.
The CiTop Guidewire passed clinical trials at several medical centers, which demonstrated that it was safe and effective in opening blocked arteries in the limbs, which other methods had failed to clear. Such blockages are usually too dense for inserting a guidewire through them, and are difficult to remove. 30% of patients with heart disease and 40% of patients with peripheral vascular diseases suffer from blocked arteries in their limbs.
Ovalum’s CiTop Guidewire is a catheter with a proprietary shape memory metal tip. The metal narrows and expands in a wave pattern that gradually tunnels into the blockage until it is cleared either back through the catheter or via other devices.
Published by Globes [online], Israel business news - www.globes.co.il - on October 24, 2007
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