LDR Spine Receives FDA 510(k) Clearance for MC+ and ROI Spinal Systems
Newly Approved Products Complete LDR’s Fusion Product Line
Austin, TX (July 26, 2005)
LDR Spine, a total spine solution company, today announced
that it has obtained 510(k) clearance from the United States
Food and Drug Administration to market two more of its
fusion spine products in the U.S. LDR Spine will begin
marketing and selling the MC+® and ROI partial vertebral
body replacement systems (PVBRs) to U.S. surgeons for
implantation in commonly used fusion techniques for the
treatment of degenerative spine disease.
The clearance to market these products in the United States
further positions LDR Spine to implement on its stated plans
to provide the U.S. surgeon community with innovative fusion
and non-fusion product lines. LDR Spine’s Easyspine®
posterior osteosynthesis system and its BF+® complementary
synthetic bone substitute obtained FDA 510(k) clearance in
Q1 2005.
“Gaining FDA approval for MC+® and ROI is a strong addition
to our existing product portfolio and helps to complete our
fusion product offerings in the U.S., which is the largest
and fastest growing segment of the global musculoskeletal
market,” said Steve Whitlock, president and CEO of LDR
Spine. “Both systems have been well received by the surgeon
community because of their simplified instrumentation and a
unique design that affords a larger grafting area.”
MC+® and ROI were designed by a strong team of neurological
and orthopedic surgeons to address unmet or underserved
needs. Both products feature a unique design that provides
surgeons with a large grafting area, an important feature
that enables placement of the implants’ weight-bearing
surfaces on the strongest areas of the vertebral endplate.
MC+® and ROI come individually packaged and sterilized, and
offer many areas of differentiation in their design,
material, instrumentation and ease-of-use.
Whitlock added, “We are the only spine company to
individually package and sterilize our products. While the
total joint market has long employed this approach, it is
only a matter of time before all spine companies’ products
are also packaged and delivered this way. LDR Spine is proud
to lead the way with this safety and efficiency feature.”
Developed in France by LDR Médical with strong surgeon
involvement, MC+® and ROI have been used successfully in
over 3000 procedures to date. More information about LDR
Spine products as well as surgical animations, videos and
clinical case examples are available at
www.ldrspine.com.
About LDR Spine
LDR Spine supplies U.S. surgeons with innovative spinal
solutions in partnership with LDR Médical of Troyes, France.
LDR Spine works closely with surgeons to develop implantable
systems and instrumentation that restore optimum stability
and mobility to patients, and make spine surgery more
reproducible and easier to perform. More information is
located at
www.ldrspine.com.
About Path4 Ventures
Founded in 2004, Path4 Ventures LLC is a management-centric
venture capital company based in Austin, Texas. The company
identifies, creates and develops opportunities in the
healthcare industry utilizing a "hands-on" management style
by taking an active role in the technologies and
opportunities in which it invests. More information is
available at
www.path4ventures.com.
Company Contact:
James Burrows, VP of Product Commercialization, LDR
(512) 344-3307
jamesburrows@ldrspine.com