DSM extends license to supply CarboSil® TSPCU for use in AxioMed Spine Corporation’s Freedom® Spinal Discs
Symptomatic degenerative disc disease is one of the most common causes of low back pain and occurs when the intervertebral discs in the spine degenerate and lose flexibility, elasticity and shock absorbing characteristics. Treatment options include spinal fusion and total disc replacements (TDRs), the use of which have grown rapidly in part due to the increasing sophistication of the devices used in the procedures. In the United States, for example, more than 570 thousand spinal fusion procedures were performed in 2011, a 4.9% increase over 2010, according to the Millennium Research Group. Growth in TDR procedures has been even more dramatic, with nearly 20 thousand procedures performed in 2011, which represents an 11.9% increase over 2010 numbers. Spinal fusion joins two or more vertebrae together, immobilizing the faulty vertebrae and eliminating pain caused by abnormal motion. TDRs are designed to replace degenerated discs and allow motion in faulty vertebrae, which can lead to diminished disability and faster recovery times. TDRs also prevent the premature breakdown of discs in adjacent levels of the spine, a potential risk in fusion surgeries.
The first generations of TDRs were a ball and socket design using metal on metal materials. As the implants evolved, new materials were incorporated into their design including polymers. DSM’s CarboSil TSPCU is an advanced copolymer that combines the biocompatibility and biostability of conventional silicone elastomers with the processability and toughness of thermoplastic polycarbonate-urethanes. The material can improve in vitro and in vivo stability and helps prevent oxidative degradation, which can lead to improved patient results and longer lasting implants. The load bearing qualities of CarboSil TSPCU help secure the total disc replacement device in place as it flexes with the natural movement of the spine. DSM’s novel materials designed specifically for the spinal market are incorporated in three TDR devices, as well as eleven dynamic stabilization applications with additional applications in development
“Spinal fusion has been the standard of care for degenerative disc treatment, but recently payer groups and insurance companies have begun lowering reimbursements for fusion procedures and questioning its cost and applications to certain patient groups,” said William Fuller, Director of Business Development, Orthopedics at DSM Biomedical. “This creates an opportunity to highlight the benefits of total disc replacements and DSM material technology as AxioMed’s Freedom Lumbar Disc undergoes clinical trials in the United States.”
AxioMed first introduced the Freedom Lumbar Disc and the Freedom Cervical Disc in Europe and received CE Mark approvals in May 2009 and May 2012, respectively, which proved instrumental in the Freedom Lumbar Disc device becoming the first elastomeric disc to receive an Investigational Device Exemption (IDE) from the U.S. FDA. The disc is currently under evaluation in an ongoing multi-center U.S. and EU IDE pivotal clinical study designed with efficacy, safety and economic endpoints.
“The viscoelastic material properties of CarboSil TSPCU and proven track record of DSM’s technology are ideal for our spinal discs,” said Patrick McBrayer, AxioMed’s President and CEO. “Our aim is to provide patients with pain relief, reduced disability and improved lifestyle by combining our companies’ innovations.”