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DePuy Synthes receives FDA clearance for thoracic insufficiency syndrome treatment

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DePuy Synthes Spine recently announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market the VEPTR/VEPTR II Vertical Expandable Prosthetic Titanium Rib Devices for the treatment of thoracic insufficiency syndrome.

The new 510(k) clearance will improve access to the treatment, which has been available since 2004. Previously, the VEPTR/VEPTR II were only available under Humanitarian Device Exemption (HDE) regulations. They are now the first spine devices to have such a change in regulatory status, according to a company press release.

The devices include a system of curved titanium rods that are surgically attached to the patient’s ribs, spine or pelvis to stabilize and straighten the spine and create a separation between ribs to potentially improve breathing and enable normal lung growth and development.

VEPTR/VEPTR II are indicated for patients who are skeletally immature and have severe, progressive spinal deformities and/or 3-D deformity of the thorax associated with or at risk of thoracic insufficiency syndrome, according to the release.

Reference: www.depuysynthes.com.