NuVasive Launches Gradient Plus(TM) Anterior Cervical Plating System
March 14 2006 - 9:00AM
PR Newswire (US)
- Offers Surgeons Three Intra-Operative Fixation Options in One
System - SAN DIEGO, March 14 /PRNewswire-FirstCall/ -- NuVasive,
Inc. (NASDAQ: NUVA), a medical device company focused on developing
products for minimally disruptive surgical treatments for the
spine, today announced the launch of its Gradient Plus(TM) Anterior
Cervical Plating System. The system is a next- generation
enhancement of the Company's Gradient CLP(TM) dynamic cervical
plate, acquired from RSB Spine LLC in June 2005. Gradient Plus(TM)
allows spine surgeons to choose, during the procedure, between
three fixation options based on the surgical requirement: fixed,
semi-constrained, or dynamic. NuVasive believes this is the only
system on the market to allow intra-operative selection of all
three plate styles, eliminating a surgeon's need to use separate
systems for each desired fixation option. This customizable system
can be used for a wide range of applications from single-level up
to five-level fusion of the cervical spine (neck). Dr. Frank
Cammisa, Jr. of The Hospital for Special Surgery in New York, said,
"Gradient Plus(TM) is currently the only system to offer fixed,
semi- constrained, and Controlled Translation construct
capabilities all in one system. This all-in-one system gives me the
security of knowing that I can accommodate many different surgical
requirements without the need for multiple systems." The Company's
"Controlled Translation" technology allows for this maximum
intra-operative flexibility. Controlled Translation incorporates
variable angle screws combined with the Company's patented Gradient
Locking System, which enables the screws to be progressively
resistant to axial compression. The result is that the plate
settles in concert with the eventual allograft implant settling
that occurs within the disc space over time, offering a better
anatomical fit. Additional design features include the product's
low profile leading edge, which translates into less soft tissue
disruption for the patient. The product also includes docking
guides, which improve a surgeon's ease of drilling, tapping and
screw insertion. As with other NuVasive surgical approaches, the
product utilizes familiar instrumentation that allows for rapid
surgeon adoption and easy insertion of the plate on to the spine.
Alexis V. Lukianov, Chairman and Chief Executive Officer of
NuVasive, said, "The launch of Gradient Plus(TM) represents another
example of the continued enhancement of NuVasive technology to
further differentiate us in the marketplace. We now provide
surgeons with the only cervical plate system that meets virtually
all of their cervical fusion needs, as opposed to past practices of
switching systems for each patient indication and anatomy." Mr.
Lukianov continued, "We are particularly excited about the ability
of Gradient Plus(TM) to combine a novel controlled translation
technology with a fixed locking option. When incorporated together
in one implant tray, we believe the system will provide the most
versatile cervical plate offering on the market with controlled
vertebral settling along with multiple screw constraint options."
Dr. Robert Bray of Cedar-Sinai Medical Center and Marina Hospital
in Los Angeles, said, "Any truly "next-generation" spine
stabilizing cervical plating system should offer a complete,
easy-to-use system. That includes multiple insertion options that
can accommodate a variety of patient scenarios and also allow
natural vertebral settling while controlling the motion of the
screw at the screw/plate interface to ensure an optimum fusion
environment. The Gradient Plus(TM) performs in all of these aspects
as a biomechanically sound system useful for a wide variety of
patient applications. I have achieved excellent results with the
system and attribute this to its ability to allow controlled graft
loading (which promotes rapid fusion) and its Gradient Locking
System which provides and maintains immediate spinal
stabilization." About NuVasive NuVasive is a medical device company
focused on the design, development and marketing of products for
the surgical treatment of spine disorders. The Company's product
portfolio is focused on applications in the over $2.9 billion U.S.
spine fusion market. The Company's current principal product
offering includes a minimally disruptive surgical platform called
Maximum Access Surgery, or MAS(TM), as well as classic fusion
implants. The MAS platform offers advantages for both patients and
surgeons such as reduced surgery and hospitalization time and
faster recovery. MAS combines three categories of current product
offerings-NeuroVision(R), a proprietary software-driven nerve
avoidance system; MaXcess(R), a unique split-blade design
retraction system; and specialized implants, like SpheRx(R) and
CoRoent(R)-that collectively minimize soft tissue disruption during
spine surgery while allowing maximum visualization and surgical
reproducibility. NuVasive's classic fusion portfolio is comprised
predominantly of proprietary saline packaged bone allografts and
internal fixation products. NuVasive also has a robust R&D
pipeline emphasizing both MAS and motion preservation products such
as Total Disc Replacement (TDR). NuVasive cautions you that
statements included in this press release that are not a
description of historical facts are forward-looking statements that
involve risks, uncertainties, assumptions and other factors which,
if they do not materialize or prove correct, could cause NuVasive's
results to differ materially from historical results or those
expressed or implied by such forward-looking statements. The
potential risks and uncertainties that could cause actual growth
and results to differ materially include, but are not limited to:
the uncertain process of seeking regulatory approval or clearance
for NuVasive's products or devices, including risks that such
process could be significantly delayed; the possibility that the
FDA may require significant changes to NuVasive's products or
clinical studies; the risk that products may not perform as
intended and may therefore not achieve commercial success; the risk
that competitors may develop superior products or may have a
greater market position enabling more successful commercialization;
the risk that additional clinical data may call into question the
benefits of NuVasive's products to patients and surgeons; and other
risks and uncertainties more fully described in NuVasive's press
releases and periodic filings with the Securities and Exchange
Commission. NuVasive's public filings with the Securities and
Exchange Commission are available at http://www.sec.gov/. NuVasive
assumes no obligation to update any forward-looking statement to
reflect events or circumstances arising after the date on which it
was made. Contact: Investors: Kevin C. O'Boyle Stephanie
Carrington/Nick Laudico EVP & Chief Financial Officer The Ruth
Group NuVasive, Inc. 646-536-7017/7030 858-909-1800 DATASOURCE:
NuVasive, Inc. CONTACT: Kevin C. O'Boyle, EVP & Chief Financial
Officer of NuVasive, Inc., +1-858-909-1800, ; or Stephanie
Carrington, +1-646-536-7017, , Nick Laudico, +1-646-536-7030, ,
both of The Ruth Group
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