| |
|
Raymedica®
Receives FDA Approval to Initiate Patient Enrollment in the HydraFlex™
Nucleus Arthroplasty System™ Clinical Trial.
MINNEAPOLIS, June 29, 2006— — 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™ Nucleus
Arthroplasty System™, 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® design.
The HydraFlex NAS™ 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™ 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.
|
|