Raymedica(R) Announces First Implantation of the HydraFlex(TM) Nucleus Arthroplasty System(TM) (NAS(TM)) Technology for Early Stage Degenerative Disc Disease (DDD)
Posted on: Wednesday, 10 May 2006, 06:00 CDT
Raymedica announced today that the first device using the HydraFlex(TM) Nucleus Arthroplasty System(TM) 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(R) 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(TM).
"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(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 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.
Source: Business Wire
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