LDR Announces FDA Clearance of the ROI-A® Oblique ALIF Cage
Austin, TX (November 1, 2011)
LDR, a privately held medical device
company offering innovative spinal implants for both
non-fusion and fusion applications, announced that it has
received 510(k) clearance from the United States Food and
Drug Administration to market the ROI-A Oblique ALIF cage.
The oblique cage complements its forerunner, the ROI-A ALIF
cage, which is designed for direct anterior insertion. When
used with the company’s integrated VerteBRIDGE plating
technology, both devices address the growing interest in the
market for stand-alone lumbar fusion technology that reduces
the need for additional anterior or posterior
instrumentation. In addition to providing the benefits of
ALIF surgery, a key feature of the ROI-A Oblique system is
the opportunity to minimize the mobilization of the anterior
vessels, without requiring the surgeon to consider a
trans-psoatic lateral approach that may present increased
neurologic risks and necessitate neuromonitoring.
Christophe Lavigne, President and CEO of LDR, comments, “We
are excited to strengthen our worldwide leadership in
stand-alone device innovation by introducing the first
oblique ALIF stand-alone cage into the U.S. market. This
follows on the heels of our recent approval in China to
market both the ROI-A ALIF and ROI-C®
Cervical cages. The ROI-A Oblique represents the latest
application of VerteBRIDGE plating technology, which has
been successfully used in more than 17,000 cage
implantations worldwide since 2008, with September 2011
marking the first month in which over 1,000 cages using
VerteBRIDGE plating were implanted.”
Dr. Federico P. Girardi, Associate Attending Orthopaedic
Surgeon at the Hospital for Special Surgery and Associate
Professor of Orthopaedics at Weill Cornell Medical College
in New York implanted the first ROI-A Oblique ALIF cage in
the U.S. and shares the company’s enthusiasm about the
product, “A critical aspect of ALIF surgery is gaining
access to the disc, especially at the L4-L5 level, where
there may be significant concerns about management of the
anterior vessels through a direct anterior approach and
navigating the nerves within the psoas through a direct
lateral approach. LDR has acknowledged and addressed these
challenges with an innovative addition to its product line.
The ROI-A Oblique ALIF cage serves a previously unmet need
in lumbar surgery, and allows me to deliver better care to
my patients.”
The oblique cage and self-guided, curved VerteBRIDGE plating
are delivered in the plane of the disc through a direct
anterolateral approach, so that the implantation may be
achieved with less exposure than may be required to place a
traditional ALIF cage or even contemporary stand-alone
systems with screws that must be inserted at divergent
angles. The system features thoughtfully designed
instrumentation including an inserter that protects
anatomical structures while implanting the cage and plating.
Clinical evaluation of the ROI-A Oblique cage began in
France in 2009 with over 150 cases completed prior to its
market introduction in the United States.
LDR was founded in 2000 by partners Christophe Lavigne,
Hervé Dinville and Patrick Richard in Troyes, France.
Currently headquartered in Austin, TX, LDR has experienced
rapid growth through product portfolio expansion and an
increasingly global presence. LDR develops unique
implantable spine devices and instrumentation designed to
support the clinical goals of surgery while making
procedures easier to perform. More information is located at
www.ldrholding.com.
For Additional Information:
Company Contact:
Joe Ross, Vice President of U.S. Marketing for LDR
(512) 344-3410
joeross@ldrspine.com