DePuy Synthes Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the VEPTR/VEPTR II vertical expandable prosthetic titanium rib devices for the treatment of thoracic insufficiency syndrome (TIS).
Though the devices were previously only available under humanitarian device exemption regulations, the new 510(k) clearance will improve access to the treatment which has been available since 2004. VEPTR/VEPTR II devices are the first spine devices to have such a change in regulatory status.
“The 510(k) clearance is a great advancement, enabling the VEPTR/VETPR II devices to now be used at the discretion of the surgeon for spine and chest wall deformities associated with TIS,” says Robert M Campbell, Jr, director of the Center for Thoracic Insufficiency Syndrome at The Children’s Hospital of Philadelphia, an inventor of VEPTR/VEPTR II devices and the first to identify TIS as a disease condition that requires specialised care and treatment. “This will likely increase the availability of the VEPTR technology for many institutions.”
VEPTR/VEPTR II devices include a system of curved titanium rods that are surgically attached to the ribs, spine or pelvis to stabilise and straighten the spine, and to create a separation between ribs to potentially improve breathing and enable normal lung growth and development. After an initial procedure, VEPTR/VEPTR II devices are lengthened as a child grows using minimally invasive techniques.
The company says that potential benefits of treatment with the VEPTR/VEPTR II devices include more normal growth patterns without spinal growth limitations, decreased deformity of the spine, more room for the lungs to grow, increased amount of daily activities because of the increased amount of space for air in the lungs and a decreased need for using ventilators.