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The RESPONSE™ Rib and Pelvic System is indicated for skeletally immature patients with severe, progressive spinal deformities such as congenital scoliosis, neuromuscular scoliosis, syndromic scoliosis and/or three-dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS).

The RESPONSE™ Rib and Pelvic System consists of longitudinal members (rods), anchors (saddles, hooks, and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) in a variety of sizes to accommodate differing anatomic requirements. The implants in the system can be assembled in a number of different configurations to accommodate the wide variety of anatomical deformities encountered by the clinician. The RESPONSE™ Rib and Pelvic System also includes surgical instruments. All implants and instruments in the system are provided non-sterile. The RESPONSE™ Rib and Pelvic System mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The subject devices are attached perpendicularly to the child's rib, thoracic vertebra, sacrum, ilium and pelvis. This mechanically stabilizes the chest wall and spine and enlarges the thorax to improve respiration and lung growth. Once the subject devices are in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery. The components of the RESPONSE™ Rib and Pelvic System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.

The VEPTR/VEPTR II device is indicated for skeletally immature patients with severe, progressive spinal deformities and/or three dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth. This would include patients with progressive congenital, neuromuscular, idiopathic, or syndromic scoliosis.

In children with or at risk of developing Thoracic Insufficiency Syndrome, the natural course of lung development is arrested due to constriction by the thorax. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The VEPTR devices are attached perpendicularly to the subject's natural ribs and lumbar vertebra or pelvis. This mechanically stabilizes the chest wall and enlarges the thorax to improve respiration and lung growth. Once the VEPTR/VEPTR II device is in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery. The VEPTR/VEPTR II devices allow assembly in a number of different configurations. All of these configurations are required to accommodate the wide variety of anatomical deformities encountered by the clinician in treating patients with or at risk of developing Thoracic Insufficiency Syndrome.