Join        Login             Stock Quote

Nuvasive (NUVA) Receives FDA Pre-Market Approval for PCM Cervical Disc System

 October 26, 2012 02:05 PM

(By Balaseshan) NuVasive Inc. (NASDAQ: NUVA) said it has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the PCM Cervical Disc System.

The PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space.

The PCM Cervical Disc is composed of cobalt chrome endplates and a central polyethylene core, materials that have a long and well-studied history of use in other orthopedic joint replacements.

[Related -Stocks Close Higher On Earnings Optimism; Facebook (FB) Jumps]

The device will be provided to patients and surgeons in the United States as an innovative option to preserve motion in the cervical spine instead of a traditional, motion-eliminating fusion procedure.

The FDA approval comes after successful completion of a prospective, multicenter randomized investigational device exemption (IDE) clinical trial that was conducted at 23 investigational sites across the United States and included 403 total treated patients.

"This device has many design considerations that make it a truly unique product offering compared to other cervical motion preserving devices. Its low-profile design enables it to be minimally disruptive to the adjacent anatomy and a viable treatment option for levels adjacent to prior fusions," said Alex Lukianov, Chief Executive of NuVasive.

[Related -Nuvasive (NUVA) Soars After Upbeat Revenue Outlook]

NUVA is trading up 1.51% at $14.13 on Friday. The stock has been trading between $11.02 and $25.99 for the past 52 weeks.

iOnTheMarket Premium


Post Comment -- Login is required to post message
Alert for new comments:
Your email:
Your Website:

rss feed

Latest Stories

article imageLong-term Relationships and Credit Scores

Unlike many commentators, I tend to think credit scores are a good read on...

article imageIn Defense Of Rolling Return Charts

Robeco’s Lukas Daalder has a bit of an issue with rolling-performance graphics. Bashing a recent chart of read on...

article imageThe S&P 500’s Worrisome Downturn In Drawdown

Last Friday I reviewed some of the bearish signals that were casting dark shadows across the US stock read on...

article imageADP: Private-Sector Employment Rises A Solid 200k In September

The pace of growth for private-sector employment picked up in September, according to this morning’s ADP read on...

Popular Articles

Daily Sector Scan
Partner Center

Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.