LDR Announces FDA Clearance of the ROI-C™ Cervical Cage
Austin, Texas (July 20, 2009)
510(k) clearance from the United States Food and Drug
Administration. The ROI-C cage, when used with the company’s
integrated VerteBRIDGE™ plating technology, offers a zero
profile, stand-alone construct for fusion in the cervical
spine. The number of Anterior Cervical Discectomy and Fusion
(ACDF) interbody devices implanted in the U.S. in 2010 is
projected to top 44,000, representing a market value of
$63.8M. ROI-C addresses the growing interest within this
market for stand-alone cervical fusion technology that
reduces the need for thick cervical plates that may
contribute to dysphagia, or difficulty swallowing.
The anatomical shape of the ROI-C cage and its integrated
plating system are designed to provide initial and long-term
stability. The self-guided, curved plating is delivered in
the plane of the disc through a direct anterior approach, so
the surgery can be achieved with less exposure than may be
required to implant a traditional cervical plate or even
contemporary stand-alone systems with screws that must be
inserted at oblique angles. The system features thoughtfully
designed instrumentation including an inserter that protects
anatomical structures when placing the cage and VerteBRIDGE
plating.
Christophe Lavigne, CEO of LDR, comments, “The entry of the
ROI-C cervical cage into the U.S. market represents a huge
step for us in continuing to provide innovative,
surgeon-friendly solutions for varied spinal pathologies.
The product builds on the success we’ve had with the MC+
device and VerteBRIDGE plating to provide surgeons with yet
another innovative and reliable solution.”
Dr. Gregory A. Hoffman of Orthopaedics Northeast, Fort
Wayne, Indiana and Dr. Paul Henry Cho, M.D. of The Center
for Neurological Disorders, Ft. Worth, Texas were the first
to implant the ROI-C in the United States.
Dr. Cho shares, “The innovative VerteBRIDGE technology
combined with well-designed instrumentation and the straight
anterior mini-open technique provides a very effective
solution for treating my patients. I was impressed with the
speed and ease of plate insertion.”
Dr. Hoffman notes, “The implant’s anatomical design and
available sizing options ensures that I can obtain great
bone-implant contact and primary stability with immediate
loading. The procedure is straightforward and the
instrumentation is simple and easy to use.”
The ROI-C represents an evolution of LDR’s MC+® implant that
has been successfully used in more than 5,000 cases
worldwide since 2002. Like the original MC+ implant, the ROI-C
cage features a domed superior surface to better match the
shape of the endplate, without requiring the removal of
important structural vertebral bone, and is available in a
variety of footprints and heights to restore the stability
of the spine. While the MC+ features a flat plate inserted
at a 50° angle into the lower vertebra, the chief
technological advancement of the ROI-C is the integration of
VerteBRIDGE plating technology, which is comprised of curved
plates that lock into both the upper and lower vertebrae and
are introduced parallel to the plane of the disc.
VerteBRIDGE plating technology was first introduced in the
company’s very successful ROI-A™ system in 2008.
Clinical evaluation of the ROI-C began in France in April,
2009 with over 350 cases completed worldwide prior to its
market introduction as a cervical cage in the United States.
LDR works closely with surgeons to develop implantable spine systems and instrumentation that restore optimum stability and mobility to patients and to make spine surgery more reproducible and easier to perform. More information is located at www.ldrholding.com.
For More Information:
Company Contact:
Dana Kolflat, Director-Marketing, LDR
(512) 344-3317
danakolflat@ldrspine.com