Archived Policies - Surgery


Vertical Expandable Prosthetic Titanium Rib (VEPTR) for Thoracic Insufficiency Syndrome (TIS)

Number:SUR705.025

Effective Date:08-01-2005

End Date:08-31-2007

Coverage:

Implantation of the Vertical Expandable Prosthetic Titanium Rib (VEPTR) device is considered medically necessary when provided according to the U.S. Food and Drug Administration’s (FDA) humanitarian device exemption labeled indications, for treatment of thoracic insufficiency syndrome (TIS) in skeletally immature patients.

The VEPTR device should not be used in patients with the following conditions:

  • Inadequate bone strength in the ribs or spine where the VEPTR device attaches
  • Absence of proximal ribs for attachment of the VEPTR device,
  • Absent diaphragmatic function,
  • Inadequate soft issue for coverage of the VEPTR device,
  • Age below 6 months,
  • Age beyond skeletal maturity (about age 14 for girls and age 16 for boys)
  • Known allergy to any of the device materials, OR
  • Infection at the operative site.

Implantation of the VEPTR device for indications other than TIS is considered experimental, investigational, and unproven.

Description:

The VEPTR is a surgically implanted device used to treat TIS in pediatric patients.  TIS is defined as the inability of the thorax to support normal respiration or lung growth.

The 3 diagnostic categories of TIS are:

  • Flail chest syndrome (big spaces between the ribs causing poor protection for the lungs and heart)
  • Rib fusion with scoliosis (ribs are stuck together and the spine is bent) 
  • Hypoplastic thorax syndrome (very small rib cage with little room for lungs to grow and expand).  Conditions include:
    1. Jeune’s syndrome
    2. Achondroplasia
    3. Jarcho-Levin syndrome
    4. Ellis van Creveld syndrome

Current alternative practices and procedures to VEPTR include surgical and non-surgical treatments.  Non-surgical treatment consists of long-term ventilator support; however without surgery this condition is frequently terminal.

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. 

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 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.

Use of the VEPTR 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.

Rationale:

FDA Information:

The FDA humanitarian device approval issued 8/24/04 was based on the results of a prospective, multi-center clinical trial involving 257 patients aged six months to fifteen years with serious defects such as:

  • progressive scoliosis
  • flail chest syndrome
  • rib fusion
  • hypoplastic thoracic syndrome

All patients enrolled in this study were treated with the VEPTR device and served as their own controls. 

Treatment with the VEPTR device has been shown to maintain or improve the alveolar ventilation rate (AVR) in 92.0% of the patients, and the patient survival rate in the VEPTR clinical trial was 95.1%, whereas this condition is frequently terminal with non-surgical treatment.  In addition, the ability of the VEPTR to be expanded allows growth of the thoracic spine and lungs while controlling severe scoliosis.

Depending on the presenting condition of the patient, any number of risks may be associated with the implantation and maintenance of the VEPTR device.  Consideration also needs to be given to the age of the patient at initial implantation, the numerous other congenital anomalies these patients can have, and their activity levels.  The Center for Devices and Radiological Health (CDRH) of the FDA determined (based on the data submitted) that the VEPTR will not expose patients to an unreasonable or significant risk of illness or injury, and the probable benefit to health from using the device outweighs the risks of illness or injury.

Summary

Expectation of any future studies is unwarranted, given that studies on these pediatric patients could not be randomized or blinded to treatment due to the anomalies treated, risk factors, and the nature of the intervention.  Although there are limited studies conducted on use of the VEPTR, reports on the surgical procedure with the VEPTR device show promise and offer eligible patients a possible alternative to ventilator dependency.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None


Medicare Coverage:

Medicare does not have a national position on this service. It is subject to local carrier discretion. Please refer to the local carrier for more information.

References:

Hell AK, Hefti F., et al.  Treatment of congenital scoliosis with the vertical expandable prosthetic titanium rib implant.  Orthopade (2004 August) 33(8):911/8

U.S. Food and Drug Administration.  CDRH Consumer Information – New Humanitarian Device Approval – Vertical Expandable Prosthetic Titanium Rib (VEPTR) – H030009. (2004 August 24) <http://www.fda.gov>.

U. S. Food and Drug Administration.  Summary of Safety and Probable Benefit Data – Vertical Expandable Prosthetic Titanium Rib (VEPTR).  (2004 August 24) <http://www.fda.gov>.

Policy History:

Archived Document(s):

Back to Top