June 2, 2004
FDA Advisory Panel Unanimously Recommends DePuy
Spine CHARITÉ® Artificial Disc For Approval
First Artificial Disc Recommended for FDA Approval in U.S. with Post-Approval
Conditions
Gaithersburg, MD - June 2, 2004 - DePuy Spine, Inc., a Johnson
& Johnson company, today reported the Orthopaedic and Rehabilitation Devices Panel
of the U.S. Food and Drug Administration (FDA) unanimously recommended approval,
with post-approval conditions, of the company’s CHARITÉ® Artificial Disc for degenerative
disc disease. The CHARITÉ® Artificial Disc is the first artificial
disc to be reviewed by the panel and recommended for FDA approval.
The CHARITÉ® Artificial Disc is intended to provide an alternative to lumbar spinal
fusion surgery. Lumbar spinal fusion surgery, which helps reduce back pain, but
limits a patient’s range of motion and may unnaturally stress adjacent anatomy,
is performed on more than 200,000 people each year in the United States.
Earl Fender, Worldwide President, DePuy Spine, said, "We are pleased with the
recommendation for approval and we will work closely with the FDA to bring this
important new option to those patients who can benefit from artificial disc technology
as soon as possible. DePuy Spine is prepared to make a major commitment to world
class training and education on a"
The unanimous recommendation for the CHARITÉ® Artificial Disc came after DePuy
Spine presented results from a two-year, 15-center randomized U.S. clinical study
of 304 patients that showed those implanted with the CHARITÉ® Artificial Disc maintained
or improved their range of motion, experienced pain relief sooner and had a higher
degree of satisfaction with the procedure than patients who received lumbar spinal
fusion surgery.
"Many of us in the medical community are excited about the potential improvements
that artificial disc technology can bring to the treatment of degenerative disc
disease,” said Scott Blumenthal, M.D., principal investigator in the CHARITÉ® Artificial
Disc clinical trial and an orthopaedic spine surgeon from the Texas Back Institute
in Plano, site of the largest number of patients enrolled in the clinical trial.
Post-approval conditions recommended by the FDA Panel concerned surgeon training,
patient implant cards, further biomechanical studies and additional followup of
clinical study patients.
Studies Presented to FDA Panel
In the two-year clinical trial presented to the FDA Panel, patients implanted
with the CHARITÉ® Artificial Disc improved more quickly than patients in the control
group. Their pain and functional test scores were statistically superior to those
of the fusion patients at many points through 12 months of follow-up, and numerically
superior at 24 months. Also, on average, patients treated with the CHARITÉ® Artificial
Disc were discharged from the hospital a half-day sooner than fusion patients.
There were no significant differences in complications between the CHARITÉ® Artificial
Disc patient group and the spinal fusion patient group.
Radiographic findings showed an average range of motion of 6.9 and 7.4 degrees
for patients with the CHARITÉ® Artificial Disc at 12 months and 24 months. Disc
space height was restored from an average of 5.7 mm pre-operatively to 13.0 mm
at 12 months and maintained at an average 12.9 mm at 24 months. At 24 months,
88% of patients with the CHARITÉ® Artificial Disc expressed satisfaction with the
procedure, compared with 81% of spinal fusion patients. When asked if they would
have the same procedure again, 82% of patients with the CHARITÉ® Artificial Disc
said they probably or definitely would, compared to 65% of fusion subjects who
answered the same way. The CHARITÉ® Artificial Disc is made of two metal endplates
and a polyethylene core that allows for motion and function very much like a normal
disc. To date, 7,000 patients have been successfully treated with the CHARITÉ® Artificial Disc, which is available in more than 30 countries throughout the world.
In the United States, the CHARITÉ® Artificial Disc is limited to investigational
use.
About DePuy Spine, Inc.
DePuy Spine, Inc., a Johnson & Johnson company, has worked and partnered with
leading clinicians, researchers, and thought leaders to develop products to treat
spine disorders for over 20 years. Today, DePuy Spine stands in the forefront
of the worldwide spine market, with a substantial sales organization in the U.S.
and an expanding worldwide distribution network. The company is committed to advancing
the knowledge of all health care professionals and their patients in addressing
spinal pathologies.