Disc Dynamics will commence a clinical study of its Dascor Disc Arthroplasty System, a catheter-based, minimally invasive nucleus replacement technology designed to treat lower back pain associated with degenerative disc disease.
The system consists of a two-part curable polyurethane and an expandable polyurethane balloon which is inserted into the disc nucleus space after the nucleus has been removed. The balloon is then injected with the flowable polymer, which creates a complete, patient specific implant that conforms to the shape and size of the disc space. The flowable polymer cures creating a firm but pliable implant. This process takes only minutes and allows for short operating times. The System replaces an abnormal disc nucleus with an artificial device that conforms to the disc nucleus space and is designed to perform like a natural healthy nucleus.
To replace the nucleus, a surgeon accesses the spine creating a small entry site into the annulus or outer portion of the disc. The abnormal nucleus is removed through the entry site, and a catheter tube with a specially designed balloon is inserted into the disc space. A balloon is filled with contrast solution that allows it to be seen on an X-ray and these images of the balloon are taken to insure proper positioning and sizing of the final implant. The catheter is then removed. Another catheter with a balloon is inserted into the disc nucleus space and a two-part polymer is injected as a liquid, filling the balloon and the disc nucleus space. When the two parts of the polymer come in contact with each other, they cure to form a firm but pliable implant that conforms to the individual's anatomy. The polymer and the balloon bond to each other to form a single implant that remains in place and is designed to restore the original disc function.
By preserving the bony structure of the spine and outer annulus, the system also retains future treatment options at the operative level should they become necessary. To date, clinical study results using the system have demonstrated that most patients have experienced improvement in pain and function.
The system has been in clinical use outside of the US since 2003. In July 2005, Disc Dynamics received the CE mark the commercial sale of the technology in Europe.
"This is a major achievement for our company, and is a direct result of the significant efforts of our employees and clinical advisors," said Steven J Healy, CEO.
|
