Healthcare Industry News: RSB Spine
News Release - March 14, 2006
NuVasive Launches Gradient Plus(TM) Anterior Cervical Plating SystemOffers Surgeons Three Intra-Operative Fixation Options in One System
SAN DIEGO, March 14 (HSMN NewsFeed) -- 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."
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®, a proprietary software-driven nerve avoidance system; MaXcess®, a unique split-blade design retraction system; and specialized implants, like SpheRx® and CoRoent®-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 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.
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