Healthcare Industry News: Hydrogel
News Release - May 17, 2006
Raymedica(R) Ten Year PDN(R) Prosthetic Disc Nucleus Clinical Results Presented at Major Spine Scientific Meeting
MINNEAPOLIS--(HSMN NewsFeed)--May 17, 2006--Study Results Related to Pain, disc height, range of motion and patient clinical outcomes with the PDN technology.Results from a 10 year clinical evaluation of patients implanted with the first generation PDN Prosthetic Disc Nucleus technology indicate the patients improved or maintained their range of motion and experienced early and sustained pain reduction.
Sponsored by Raymedica, the details of the retrospective analysis and the findings were presented at the 6th Annual Spine Arthroplasty Society (SAS) meeting in Montreal, QC, Canada.
"These 10 year results suggest that the PDN Prosthetic Disc Nucleus technology has a significant positive effect on pain, function and range of motion after nucleus replacement surgery," said Robert Schonmayr, MD, PhD, the principal clinical investigator and neurosurgeon at the Horst-Schmidt Kliniken fur Neurochirurgie, Wiesbaden, Germany, who presented this data during the May 12th scientific session. In the clinical evaluation, patients implanted with the PDN technology experienced improvement in pain and functional status as compared to their preoperative status.
Radiographic findings included average range of motion of 5.2 degrees at the operated level for patients implanted with the PDN at 10 years. Disc space height had slightly decreased from an average of 10.4 mm immediately post-operatively to an average of 8.3 mm at 10 years.
Patients were evaluated immediately following surgery, again at 3, 6, 12, 24, 60 and 120 months. All patients were seen at key follow-up time points, with 100% follow-up at the 10 year time point, an important measure for this type of study.
All 10 patients are fully working, 3 reported sporadic minor low back pain, 1 patient occasionally had to take analgetics because of low back pain after heavy work.
9 out of the 10 patients implanted with the PDN expressed satisfaction with the technology and procedure. When asked if they would have the same procedure again, 9 patients implanted with the PDN said they "definitely would" undergo the procedure again.
Raymedica's PDN technology is a proprietary pre-formed Hydrogel encased in a polyethylene jacket that has flexibility to facilitate delivery through a standard posterior approach and allows conformability to adapt to the human intervertebral disc space.
"These 10-year results confirm that the PDN prosthetic disc nucleus device shows excellent performance related to functional improvement and biocompatibility performance and will serve as a reference for our latest version, the HydraFlex(TM) Nucleus Arthroplasty System(TM), where comparable long-term data is currently not available" stated John J. Viscogliosi, Chairman and CEO of Raymedica.
About Raymedica
Raymedica, based in Minneapolis, Minnesota, is the Pioneer in Nucleus Arthroplasty(TM) having developed the world's first nucleus replacement device in 1996. Raymedica develops, manufactures and markets medical device systems designed to treat patients with degenerative disc disease that have not responded to non-surgical treatment. Raymedica's products are currently available worldwide, but are limited to investigational use only in the United States. For more information, visit the Company's website at http://www.raymedica.com.
Source: Raymedica
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