A Medical Device Daily
Raymedica (Minneapolis) yesterday reported that it has received FDA approval to begin enrolling patients in a U.S. clinical study to evaluate the benefits of its HydraFlex Nucleus Arthroplasty System (NAS), which it describes as a new non-fusion technology for the treatment of degenerative disc disease.
Implanted via an anterior lateral retroperitoneal approach (ARPA), the HydraFlex device is designed to replace the diseased nucleus, providing pain relief and maintaining disc height. Raymedica said that the HydraFlex is designed with its pre-formed contained hydrogel technology implanted in more than 4,000 patients over the past 10 years.
It says the HydraFlex NAS has design features that provide a more anatomic contoured shaped device for greater fit and fill; a softer core with a larger footprint to reduce the risk of subsidence; and faster hydration to allow more rapid stabilization in comparison to the company's PDN-SOLO design.
The HydraFlex NAS also incorporates co-functioning instrumentation designed to provide reproducible intra-discal sizing with consistent placement of the device during implantation. The ARPA permits a more thorough consistent nucleus cleanout, the ability to repair the annular incision and is a less destabilizing approach.
Raymedica manufactures systems for treating patients with degenerative disc disease that have been previously unresponsive to non-surgical treatment.