Raymedica(R) Receives FDA Approval to Initiate Patient Enrollment in the HydraFlex(TM) Nucleus Arthroplasty System(TM) Clinical Trial
Posted on: Thursday, 29 June 2006, 06:00 CDT
Raymedica today announced that it has received FDA approval to begin enrolling patients in a US clinical study to evaluate the potential benefits of its HydraFlex(TM) Nucleus Arthroplasty System(TM), a new non-fusion technology for the treatment of degenerative disc disease.
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(R) design. The HydraFlex NAS(TM) 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.
"We are very pleased with the opportunity to begin this clinical trial and look forward to working with the FDA in the months ahead on satisfying the requirements for approval of our pivotal IDE study" commented John J. Viscogliosi, Chairman and CEO of Raymedica. Mr. Viscogliosi further stated, "This is an important milestone for Raymedica and I am appreciative of the work that our product development and regulatory team has done to secure FDA IDE approval."
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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