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Orthopedic and Dental Industry News

May 2009

FDA Approves Medtronic's Bryan Cervical Disc BY JOHN MCCORMICK, MAY 29, 2009

Medtronic received long-awaited FDA approval for its Bryan cervical disc on May 12. The device received a favorable FDA panel recommendation in July of 2007, just a day after Medtronic's Prestige disc was approved for market launch. Under the conditions... more

Musculoskeletal News Roundup 28-May-09 BY LAUREN UZDIENSKI, MAY 28, 2009

Regulatory Blackstone Medical received an FDA warning letter relating to the ICON Modular Spinal Fixation System, which the company voluntarily recalled in December of 2005. The FDA said Blackstone failed to adhere to its own risk management procedures and failed... more

To Draw Patients, Hospitals Webcast and Twitter Surgeries BY LAUREN UZDIENSKI, MAY 26, 2009

As hospitals face uphill battles on funding and reimbursement, some centers have adopted high-tech ways of reaching out to potential patients, including webcasting surgeries and twittering. In cases cited by the New York Times, Methodist University Hospital in Memphis broadcast... more

Ancient Artifacts Offer a Glimpse into Early Cosmetic Dentistry BY LAUREN UZDIENSKI, MAY 26, 2009

Decorating one's teeth in gold and diamonds may have been popularized by today's hip-hop stars, but new artifacts from southern North America show not only that dental bling was around 2,500 years ago, but that it was the work of... more

FDA Panel Recommends Approval for Duraseal in Spinal Surgery BY LAUREN UZDIENSKI, MAY 22, 2009

Last week an FDA panel voted 4-0 in favor of broadening the approved applications for Covidien's Duraseal sealant to include spinal surgery. Duraseal is a resorbable polymer gel designed, along with sutures, to close small gaps in the dura mater... more

Musculoskeletal News Roundup 21-May-09 BY LAUREN UZDIENSKI, MAY 21, 2009

Earnings Medtronic reported FQ4:09 revenue of $3.8 billion, representing a 5% increase (constant currency) over FQ4:08 and in line with estimates. Adjusted EPS for the quarter was $0.82, also in line with estimates. Spine and biologics revenue was $881.0 million,... more

More Trouble for InFuse as Fraudulent Data Makes Headlines BY LAUREN UZDIENSKI, MAY 20, 2009

The New York Times reported last week that a former surgeon at Walter Reed Army Medical Center falsified data on InFuse that was published in (and later retracted by) JBJS. The study in question evaluated the use of InFuse for... more

Preemption at Issue in Medical Device Safety Act of 2009 BY LAUREN UZDIENSKI, MAY 20, 2009

Last year's Riegel v. Medtronic Supreme Court case upheld preemption for medical devices, meaning FDA approval superseded any action that could be brought against a manufacturer in state court, effectively preventing product-liability lawsuits. That ruling is being challenged in the... more

FDA to Offer $2M in Pediatric Device Grants BY LAUREN UZDIENSKI, MAY 18, 2009

The FDA is offering $2.0 million in grants to support the development of medical devices for pediatric patients. The aim of the grants is to encourage devices designed specifically for the "size, growth, development and body chemistry" characteristics of pediatric... more

Musculoskeletal News Roundup 14-May-09 BY LAUREN UZDIENSKI, MAY 14, 2009

Earnings aap Implantate reported 1Q:09 revenues of EUR 8.4 million ($11.1 million), representing a 5% increase over the year-ago period. EBITDA for the quarter declined 47% to EUR 0.05 million ($1.1 million). The company says that for the full-year 2009,... more

FDA to Evaluate Clearance Process for ReGen's Menaflex BY LAUREN UZDIENSKI, MAY 13, 2009

The Wall Street Journal reports that the FDA will review its clearance of ReGen Biologics' Menaflex device. The Journal previously alleged that ReGen had undue influence on the regulatory process, making campaign donations to politicians who lobbied for the device's... more

In a Troubled Economy, Companies Weigh the Value of Conference Attendance BY LAING RIKKERS, MAY 12, 2009

As you might expect in times of economic uncertainty, companies are taking a hard look at their expenses and questioning what is essential and what is not. One of the areas that is under the microscope is spending on conference... more

Payers, Trade Groups and Physicians Pledge to Curb Growth of Healthcare Costs BY LAUREN UZDIENSKI, MAY 12, 2009

President Obama is moving ahead with U.S. healthcare reform, and yesterday he provided an overview of part of his plan with a coalition of insurers, industry groups and physicians behind him. During the 1990s, President Clinton's push for a healthcare... more

Spine Arthroplasty 9: London Calling BY JOHN MCCORMICK, MAY 7, 2009

If any spine surgeon congress serves as a litmus test on sentiment concerning new surgical technology, the Spine Arthroplatsy Society ("SAS") meeting is the one. SAS was founded nearly 10 years ago by forward thinking surgeons and technology developers seeking... more

Musculoskeletal News Roundup 7-May-09 BY LAUREN UZDIENSKI, MAY 7, 2009

Earnings Alphatec Spine reported record consolidated revenue of $30.6 million reported in 1Q:09, which represents 32% growth over 1Q:08 and 8% sequential growth over revenues reported in 4Q:08. U.S. revenue growth of 28% over prior year was approximately three times... more

CMS Proposes Payment Increases for 2010 BY LAUREN UZDIENSKI, MAY 4, 2009

CMS released its draft FY2010 IPPS schedule on Friday. At a glance, the 1,200-page document seems to bode well for ortho, and relatively significant payment increases may help offset some of the concerns about pricing pressure that have dogged the... more

Alphatec Spine Introduces the GLIF (Guided Lateral Interbody Fusion) Technique and the ARC Portal Access System BY EDITOR, MAY 4, 2009

Alphatec Holdings, Inc., the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, introduced... more


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