This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Integra LifeSciences Receives FDA Clearance For Expanded Indication For Spinal Device

PLAINSBORO, N.J., Oct. 9, 2012 (GLOBE NEWSWIRE) -- Integra® LifeSciences Holdings Corporation (Nasdaq:IART) today announced that the Food and Drug Administration (FDA) has approved an expanded indication for use of the Integra® Vu aPOD™ Prime Intervertebral Body Fusion Device (IBD) in anterior lumbar interbody fusion (ALIF) procedures. The new stand-alone indication includes four points of fixation, which is composed of two screws and a SpinPlate™. The Integra® Vu aPOD™ Prime IBD will be featured at the Congress of Neurological Surgeons (CNS) annual meeting, October 6 – 10, 2012, in Chicago, Illinois.

"Earlier this year the Vu aPOD™ Prime IBD entered its full market release with stand-alone indications," said Kirt Stephenson, President, U.S. Spine. "We're pleased that with this additional indication, we can now provide surgeons with multiple fixation options to best meet their patients' needs."

IBDs are designed to help provide stability for spinal fusion after a diseased lumbar disc is surgically removed. They are small, hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and allow fusion between vertebral bodies. These devices relieve pressure on the nerves and provide positive mechanical stabilization of the vertebrae. The graft window in the device is packed with bone and provides an environment in which natural bone growth can occur, which then enables fusion of the vertebral segments.

Traditionally, surgeons use supplemental fixation to help hold the IBD in place. However, the Integra® Vu aPOD™ Prime IBD features two zero-profile options utilizing two screws or two screws and a SpinPlate™ to help secure the IBD in its functional position, eliminating the need for supplemental fixation implants, and reducing the number of steps and implants required to perform an ALIF procedure.

"The Integra® Vu aPOD™ Prime IBD provides surgeons with an easy and safer approach when compared to other devices that have four points of fixation with four screws, and a very minimally invasive way to provide stability of the anterior lumbar spine, with no additional sharp objects introduced to the outside of the spine," said Jaideep Chunduri, MD, a design surgeon from Beacon Orthopaedics and Sports Medicine in Cincinnati, Ohio. "It is often difficult to place screws laterally within the lumbar spine. Integra's SpinPlate™, in conjunction with two screws, enables four-point fixation without significant retraction. Because the SpinPlate™ is also located within the middle of the device, and provides built-in fixation, there is no added risk in terms of blood loss or vascular tissue. "

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

DOW 17,619.51 +23.16 0.13%
S&P 500 2,063.12 +5.48 0.27%
NASDAQ 4,986.8670 +28.3990 0.57%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs