LDR Announces FDA Clearance of its ROI-A™ ALIF Device
Austin, TX (April 2, 2009)
LDR, a total spine solution company, announced that it
received FDA clearance on Feb. 2 to market its ROI-A™
implant as an anterior lumbar interbody fusion (ALIF)
device. Previously cleared in April 2008 as a partial
vertebral body replacement, the ROI-A™ system incorporates
the innovative VerteBRIDGE™ screwless plating technology.
The ROI-A™ ALIF is a stand-alone implant system with zero
profile, self-locking plates designed for initial and
long-term stability. The surgical technique is a direct
anterior approach, with the curved plates inserted along the
sagittal plane thus requiring no additional exposure to the
vertebral bodies.
The ROI-A™ ALIF device is made of PEEK-Optima® for
biocompatibility and radiolucency along with Tantalum
markers for verification of implant positioning. The system
is comprised of multiple footprint sizes, lordotic angles
and heights for optimized fit per anatomical requirements.
An innovative inserter holds the implant, protecting
vascular structures and guiding the plates during insertion.
Christophe Lavigne, CEO of LDR, comments, “Since launching
the system in the United States in 2008, close to 500 of the
ROI-A devices have been implanted with extremely positive
feedback from the surgeons. We are very optimistic about the
future of this device for ALIF procedures.”
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