FDA Crackdowns Dampen US Pedicle Screw-Based Dynamic Stabilization System Market

WALTHAM, Mass., July 13 /PRNewswire/ -- According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, because of a lack of clinical data proving device safety and efficacy, the FDA released 522 postmarket surveillance study letters to manufacturers in late 2009 requesting additional clinical data to support the use of pedicle screw-based dynamic stabilization systems as an adjunct to fusion.

As per the requirements of the 522 letters, companies that manufacture pedicle screw-based dynamic stabilization systems must provide the FDA with clinical data showing their devices' efficacy and safety; however, many companies do not have this clinical data available because it was not required as a part of the devices' original 510(k) clearance and because the devices themselves are more frequently implanted by surgeons offlabel. Also, the cost of performing a clinical trial to obtain this data is beyond the financial capabilities of some of the companies at this time. Some of the larger spine companies, such as Alphatec Spine and Globus Medical, are better positioned to provide the necessary clinical data. Smaller companies with less financial reserves, however, or companies with products not yet on the market, may terminate their dynamic rod construct portfolios and concentrate on other products that require less financial investment.  

The market will also be impacted by the FDA's recommendation against approval for Zimmer Spine's Dynesys as a spinal nonfusion technology.  This recommendation stemmed from the risk of unfavorable outcomes, such as screw loosening, and an unclearly defined patient population. Due to the perceived lack of evidence for a nonfusion indication by the FDA, some surgeons are now less inclined to use the Dynesys offlabel, which accounts for a large portion of the device's use. Subsequently, Zimmer Spine's sales of the device have and will continue to be negatively impacted.

"Because of this, a number of systems that had been expected to enter the market are no longer anticipated to enter before 2014," says Deanna Vankessel, Senior Analyst at MRG. "Also, some surgeons will limit their use of these systems until more data become available or until a device is released that has approval for nonfusion applications. This isn't expected until 2013, when Applied Spine Technologies is set to launch its Stabilimax, which will be the first dynamic rod construct approved for nonfusion indications."

MRG's US Markets for Spinal Implants 2010 report provides critical insight into emerging trends that will fuel the long-term outlook of the markets for spinal fusion implants and nonfusion technologies in the US.

About Millennium Research Group

Millennium Research Group (www.MRG.net), a Decision Resources, Inc. company (www.DecisionResourcesInc.com), is the global authority on medical technology market intelligence and the leading provider of strategic information to the healthcare sector. The company provides specialized industry expertise through multiclient market research, ongoing Marketrack™ projects, customer behavior tracking, facility-level procedure forecasting, and customized solutions.

About Decision Resources, Inc.

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information, and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

SOURCE Millennium Research Group

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