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Raymedica®
Announces First Implantation of the HydraFlex™ Nucleus Arthroplasty
System™ (NAS™) Technology for Early Stage Degenerative Disc
Disease (DDD)
MINNEAPOLIS, May 10, 2006— Raymedica announced today that the first
device using the HydraFlex™ Nucleus Arthroplasty System™ was
implanted at Kreiskrankenhaus in Bogen, Germany, on April 13 by Dr. med.
univ. Rudolph Bertagnoli,. Dr. Bertagnoli is one of three international
surgeons participating in a Raymedica sponsored clinical evaluation of
the HydraFlex Nucleus Arthroplasty System intended to provide safety and
effectiveness data regarding this emerging technology.
The HydraFlex Nucleus Arthroplasty System is designed specifically for
use in a less invasive Anterior lateral RetroPeritoneal Approach (ARPA).
The HydraFlex System incorporates instrumentation that allows controlled
repeatability, reproducibility and permits consistency of implantation.
The ARPA allows a more thorough, consistent nucleus cleanout and the ability
for closure of the annular incision. Also of importance is that the ARPA
is less destabilizing to the lumbar motion segment than the traditional
posterior approach.
“I believe HydraFlex represents the next generation in nucleus arthroplasty
technologies,” said Dr. Bertagnoli, Chief of the Spine Department
Klinikum St. Elisabeth, in Straubing, Germany. “Ease of insertion
and intraoperative versatility make it a very welcome advancement to the
surgical options spine surgeons currently possess. I am very excited to
participate in its clinical evaluation.”
The HydraFlex device is designed with the Raymedica’s same proprietary
pre-formed hydrogel technology that has been used in over 4000 patients
over 10 years. Using the PDN-SOLO® family as a platform, an optimization
program consisting of a more anatomic shape of the implant for a better
fit and fill of the disc space, softer core to reduce the risk of subsidence,
faster hydration to allow faster stabilization, increasing the hydrogel
footprint to reduce pressure on the vertebral endplates, coupled with
elegant instrumentation, has resulted in the HydraFlex NAS™.
“Raymedica continues to deliver innovative systems that maintain
or restore motion preservation of the spine,” said John J. Viscogliosi,
Chairman and CEO of Raymedica. “Nucleus Arthroplasty procedures
are one of the fastest growing segments of spine surgery, and HydraFlex
will provide spine surgeons with a unique nucleus replacement option.”
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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