|[August 28, 2013]
LDR Receives First FDA Approval for Two-Level Cervical Disc Replacement
AUSTIN, Texas --(Business Wire)--
LDR, a privately held medical device company offering exclusive spinal
implant technologies for both non-fusion and fusion applications, today
announced that it has received a letter of approval from the U.S. Food
and Drug Administration (FDA) allowing the commercial sale and
distribution of the Mobi-C Cervical Disc (Mobi-C) for two-level
indications, making it the first and only cervical disc in the United
States approved to treat more than one level of the cervical spine. LDR
previously received a letter of approval on August 7, 2013 from the FDA
allowing the commercial sale and distribution of the Mobi-C for
"We are very pleased that the FDA, after an intensive review of our
submissions, has determined that Mobi-C is safe and effective for both
one and two-level indications in the United States, and superior to
fusion for two-level cervical disc replacement, based on the results of
our prospective, concurrently controlled and randomized, multi-center
clinical trials," said Christophe Lavigne, president and CEO of LDR. "We
are proud that LDR is first to offer an on-label, arthroplasty solution
for the significant number of patients suffering from two-level cervical
disc disease. It is very gratifying to know that spine surgeons can now
offer this new, evidence-based treatment option to their two-level
Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing
prosthesis specifically designed as a bone-sparing, cervical
intervertebral disc replacement for both one and two-level indications.
In addition to the unique mobile-bearing feature, Mobi-C offers a
simplified surgical technique as compared to other, commercially
available devices, all of which are approved for one-level use only.
In the two-level arm of the Investigational Device Exemption (IDE)
trial, Mobi-C demonstrated superiority in overall trial success compared
to anterior cervical discectomy and fusion (ACDF), which is a standard
option for treating cervical degenerative disc disease. Specific
findings comparing Mobi-C to ACDF in the two-level study at the 24-month
Mobi-C implanted at two contiguous levels demonstrated statistical
superiority in overall trial success compared to ACDF. The difference
between Mobi-C's overall success rate of 69.7% and ACDF's rate of
37.4% represented statistical superiority (p< 0.0001).
The rate of secondary surgery at the index level for Mobi-C was
3.1% versus 11.4% for ACDF.
The percentage of subjects who demonstrated negative radiographic
changes from baseline in adjacent segments was:
2.9% of Mobi-C patients compared to 18.1% of ACDF patients at the
inferior adjacent level; and
13.1% of Mobi-C patients compared to 33.3% of ACDF patients at the
superior adjacent level.
Mean return to work time was 45.9 days for Mobi-C compared to 66.8
days for ACDF.
Mobi-C showed 78.2% improvement in Neck Disability Index (NDI) based
on success criteria versus 61.8% for ACDF.
Mobi-C is a safe and effective surgical option at two contiguous
levels in the cervical spine from C3 (News - Alert)-C7 for indicated patients.
"The study data supporting the FDA Approval for Mobi-C represents Level
I evidence-the highest level of data classification achievable in the
field of Evidence Based Medicine," said Dr. Reginald Davis, Director of
Neurosciences at GMBC in Baltimore, Maryland. "As a spine surgeon I have
been following the positive clinical data supporting cervical disc
replacement over the last several years including the long term
evidence. I believe that the two-level Mobi-C study conclusions
represent a landmark event in spine, as for the first time it has been
demonstrated that on-label two-level cervical disc replacement with
Mobi-C represents a superior treatment to two-level anterior spinal
"Mobi-C is unique in that it is now the only cervical disc replacement
FDA approved for both one and two-level clinical use," said Dr. Gregory
A. Hoffman (News - Alert), orthopedic surgeon and member of the SpineONE Medical Team
at Ortho North East in Fort Wayne, Indiana. "The population of patients
suffering from one or two-level cervical disc disease is large, and
Mobi-C has the potential to make a significant and positive impact to
the treatment of those patients."
"This has been a long and rewarding process," continued Lavigne. "I
would like to thank and attribute this success to everyone involved in
this study, especially the clinicians, study coordinators, the FDA, LDR
employees, our partners and suppliers, and most importantly the patients
who consented to participate in the first concurrent one and two-level
prospective study performed comparing cervical disc replacement to ACDF."
LDR, founded in Troyes, France, and headquartered in Austin,
Texas, is a global medical device company focused on designing and
commercializing novel and proprietary surgical technologies for the
treatment of patients suffering from spine disorders. Exclusive LDR
technologies are based on the Mobi non-fusion and VerteBRIDGE® fusion
platforms which have applications in cervical and lumbar spine. In
addition to Austin and Troyes, LDR has regional offices in Germany,
Spain, China, Korea and Brazil. More information regarding LDR and the
Mobi-C Cervical Disc can be found at www.ldr.com
The Summary of Safety and Effectiveness for P110009 is available at www.fda.gov.
[ Back To Technology News's Homepage ]