DePuy Synthes Spine announced its VEPTR/VEPTR II Vertical Expandable Prosthetic Titanium Rib Devices received 510(k) clearance from the U.S. Food and Drug Administration.
The devices are intended for the treatment of thoracic insufficiency syndrome, a rare congenital condition. The devices were previously available only under Humanitarian Device Exemption regulations. The new 510(k) clearance will improve access to the treatment which has been available since 2004. These devices are the first spine devices to have such a change in regulatory status.
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