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24
Month Preliminary Results of a Multi-Center International Study of the
PDN-SOLO® Nucleus Replacement Device to be Presented at the 6th Annual
Spine Arthroplasty Society Meeting.
MINNEAPOLIS, May 8, 2006— The interim results of an ongoing study,
“An International Multi-Center Clinical Evaluation of the PDN-SOLO®
Device” conducted by Raymedica will be presented for the first time
at the 6th Annual Spine Arthroplasty Society Meeting being held at the
The Palais des Congres de Montreal. The presentation will given by Chan-Shik
Shim, MD, PhD, of the Wooridul Spine Hospital, Seoul, Korea, on Wednesday,
May 10, 2006, at 10:55 a.m., during the 10:30 a.m. to 12:30 p.m. Raymedica
Workshop Session.
Patients in the study were implanted with the PDN-SOLO device via a Posterior
PDN Approach (PPA), an approach very similar to a microdiscectomy. The
preliminary clinical outcomes of 67 patients are to be presented illustrating
the clinical effectiveness of the PDN-SOLO device.
The 24 month results reveal that patients treated with the PDN-SOLO device
via the posterior approach achieve a 63% improvement of their back pain
Visual Analog Score with a decrease from 7.3 pre-op to 2.7 at the 24 month
time point. The Oswestry Disability Index decreased from 52 % pre-op to
14% at the 24 month time point, a 73% improvement. The Visual Analog Score
and Oswestry Disability Index are validated tests commonly used to assess
the benefits of treatment for spinal procedures.
“The data presented here is another confirmation of the clinical
experience with the PDN-SOLO device for safely treating degenerative disc
disease,” said Dr. Chan-Shik Shim Vice-President of Academic Affairs,
at Wooridul Spine Hospital. “We expect these good results to be
maintained as we continue to follow these patients and the data matures.”
“The 24 month clinical results of the PDN-SOLO device demonstrate
our continued commitment to our core proprietary pre-formed hydrogel technology
that provides benefits for surgeons and their patients,” said John
J. Viscogliosi, Chairman and CEO of Raymedica. “Innovative and effective
nucleus arthroplasty systems are the cornerstones of our business focus
and we will continue to optimize our product portfolio in the future.”
The co-investigators of this study include: Björn Branth, MD, Stockholm
Spine Center, Stockholm, Sweden; Christian Brinkmann, St. Josef-Stift
Hospital, MD, Sendenhorst, Germany; Robert Schönmayr, Horst-Schmidt
Kliniken, Wiesbaden, Germany; Panagiotis Selviarides, MD, AHEPA University
Hospital, Thessaloniki, Greece; and Mehmet Zileli, MD, Ege University
Hospital, Izmir, Turkey.
About Raymedica
Raymedica, based in Minneapolis, Minnesota, is the Pioneer in Nucleus
Arthroplasty™ 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 been unresponsive to non-surgical treatment. Raymedica’s products
are currently available in many countries 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.
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