Raymedica, Inc., a Minneapolis-based developer and manufacturer of prosthetic disc nuclei aimed at preserving the motion of the spine, has been recognized by Frost & Sullivan at the 2008 Excellence in Medical Technologies & Life Sciences Awards. The company has developed two product platforms, called PDN-SOLO® and HydraFlex™, both thought to be designed for treatment of patients that “fall in gap of being under-treated by a discectomy but over-treated by more invasive spine surgery,” according to Frost & Sullivan. The FDA has granted an approval for the company to perform a clinical evaluation of its HydraFlex Nucleus Arthroplasty System for the treatment of DDD.
Here’s what Raymedica says about its HydraFlex device, that features the firm’s proprietary hydrogel technology:
Nucleus Arthroplasty non-fusion technology goes beyond nucleus replacement and involves a comprehensive systematic approach to DDD. It is not only the implant that is important in Nucleus Arthroplasty motion preservation procedures, but the consideration of many factors including proper patient selection, indications, surgical technique/approach, and post-operative rehabilitation. Nucleus Arthroplasty motion preservation technology involves a complete spectrum of treatment. The systematic approach of Nucleus Arthroplasty motion preservation technology is better suited to providing predictable and successful outcomes than the device-only approach of nucleus replacement…
Implanted via an Anterior lateral RetroPeritoneal Approach (ARPA), the HydraFlex device is designed to replace the diseased nucleus potentially providing pain relief and maintaining disc height. The HydraFlex device is designed with the Company’s same proprietary pre-formed contained hydrogel technology that has been implanted in over 4,000 patients over the past 10 years.
The HydraFlex Nucleus Arthroplasty System has distinct design features that provide a more anatomic contoured shaped device for greater fit and fill; a softer core with a larger footprint to potentially reduce the risk of subsidence; and faster hydration to allow faster stabilization in comparison to the Company’s pioneering PDN-SOLO® design. The HydraFlex NAS™ incorporates new co-functioning instrumentation that is designed to provide repeatable/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. This device and system approach is collectively designed to potentially improve clinical performance.