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New Humanitarian Device Approval

Vertical Expandable Prosthetic Titanium Rib (VEPTR) - H030009

FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Vertical Expandable Prosthetic Titanium Rib (VEPTR)
Manufacturer: Synthes Spine Co.
Address: 1230 Wilson Drive, West Chester, PA 19380
Approval Date: August 23, 2004
Approval Letter: http://www.fda.gov/cdrh/ode/H030009sum.html

What is it? The Vertical Expandable Prosthetic Titanium Rib (VEPTR) is a surgically implanted device used to treat Thoracic Insufficiency Syndrome (TIS) in pediatric patients. TIS is a congenital condition where severe deformities of the chest, spine, and ribs prevent normal breathing and lung growth and development. The VEPTR device is a curved metal rod that is attached to ribs near the spine using hooks located at both ends of the device. The VEPTR device helps straighten the spine and separate ribs so that the lungs can grow and fill with enough air to breathe. The length of the device can be adjusted as the patient grows.

How does it work? During surgery, the VEPTR device is adjusted to fit the patient and attached vertically on the patient’s ribs near the spine. Lengthening the device enlarges the rib cage and increases the amount of lung space in the patient’s chest. The VEPTR device will be lengthened or replaced at specific times to allow for the patient’s growth and to further correct spinal or chest wall deformity. Adjustments to the length of the VEPTR device are made during surgery through a small cut (incision) in the patient’s back.

When is it used? The VEPTR device is used to treat TIS in pediatric patients.

What will it accomplish? Use of the VEPTR device may result in:

• a more normal growth pattern without spinal growth limitations,
• decreased chest, spine and rib deformity,
• expanded lung volume,
• increased life span,
• decreased dependence on a supplemental air supply,
• increased physical activity capability, and
• improved psycho-social health.

When should it not be used? The VEPTR device should not be used to correct conditions other than chest wall instability.
The VEPTR device should not be used in patients who:

• lack bone strength in the ribs or spine where the VEPTR device attaches,
• do not have ribs near where the VEPTR device needs to be placed,
• do not have frontal ribs for attachment of the VEPTR device,
• do not have a functioning diaphragm,
• do not have enough soft tissue to cover the VEPTR device,
• are younger than 6 months of age,
• are skeletally mature (about age 14 for girls and age 16 for boys),
• have a known allergy to any of the device materials, or
• have an infection at the surgical site.

Additional information:

SSPB and Labeling: http://www.fda.gov/cdrh/ode/H030009sum.html

Updated September 14, 2004

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