FDAnews Device Daily Bulletin

FDA OKs DePuy Synthes Treatment for Childhood Skeletal Disorder

Dec. 9, 2014

DePuy Synthes Spine said Friday that it has won FDA 510(k) clearance for its VEPTR and VEPTR II vertical expandable prosthetic titanium rib devices for the treatment of thoracic insufficiency syndrome. The rare congenital condition causes severe deformities in the chest, spine and ribs, which impacts breathing and lung growth in children.

The VEPTR devices are comprised of curved titanium rods, which are surgically attached to the ribs, spine or pelvis to stabilize and straighten the spine, promoting normal growth and development. After initial implantation, the devices can be expanded via minimally invasive procedures as the child grows to allow for greater lung capacity, the Johnson & Johnson subsidiary says. 

The treatment has been available since 2004 under a humanitarian device exemption.

Children’s Hospital of Philadelphia surgeon Robert Campbell, Jr., an inventor of the VEPTR and VEPTR II, says the broader 510(k) clearance will likely result in more hospitals and surgeons offering the treatment for TIS. — Kellen Owings

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