AUSTIN, Texas–(BUSINESS WIRE)–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 companys
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 companys 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.
