Synthes, Inc. announces FDA approval of patented Vertical Expandable Prosthetic Titanium Rib (VEPTR)
Philadelphia (PA)/USA and Oberdorf/Switzerland, September 9, 2004Synthes, Inc. is a leading global medical device company specializing in the development, manufacturing and marketing of orthopedic instruments and implants. Applications include surgical treatment of bone and maxillofacial trauma or deformities and a full range of products for spine surgery.
Synthes Spine is pleased to announce the approval by the Food and Drug Administration of the patented Vertical Expandable Prosthetic Titanium Rib (VEPTR) device as a Humanitarian Device Exemption (HDE) for the treatment of Thoracic Insufficiency Syndrome (TIS).
Thoracic Insufficiency Syndrome is the inability of the thorax to support normal respiration or lung growth. It occurs in young children with severe rib and chest wall malformations often associated with scoliosis. The VEPTR is designed to stabilize the thorax while enlarging the abnormal chest wall through periodic lengthening as the child grows.
The surgical procedure was developed more than 12 years ago by Robert Campbell. M.D. and Melvin Smith, M.D. of CHRISTUS Santa Rosa Children’s Hospital in San Antonio, Texas. They recognized the need for VEPTR after seeing too many young children die from the complications of TIS for which there was no effective treatment option. Dr. Campbell believes that with the VEPTR, “we are, for the first time, able to treat three-dimensional problems with three-dimensional thinking and techniques. This is a radical change to the standard of care for the treatment of Thoracic Insufficiency Syndrome, allowing children with TIS a better chance at a more normal life”.
The VEPTR device has been part of a multi-center Investigational Device Exemption study since 1996. Over 250 children have been treated by eight pediatric spine surgeons at children’s hospitals across the country. The VEPTR is also being used clinically in Europe and Canada.
An HDE approval authorizes the marketing of a Humanitarian Use Device (HUD), which is a device that is “intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals per year.” The HUD classification is created solely for the purpose of benefiting patients with rare conditions.
According to Michael Huggins, President of Synthes Spine, the VEPTR would not be possible without the continued support of the FDA and the collaboration of Synthes, the investigating surgeons, the families of these young patients and the FDA throughout the clinical trial. “We are extremely proud of the VEPTR project and the dedicated surgeons who believe in its potential to make a huge difference in the lives of children with TIS”.
For further information please contact
Peter Fehlmann, Investor Relations, Synthes, Inc.
Phone: +41 32 720 48 10 , Fax: +41 32 720 48 11
e-mail: ir.info@synthes.com