UPDATE 1-US panel rejects wider use of Zimmer spine device

* FDA advisory committee votes 5-1 against approval

* Advisers say data unclear, question long-term impact

GAITHERSBURG, Md., Nov 4 (Reuters) – A U.S. panel of medical experts on Wednesday recommended against wider use of a Zimmer Holdings Inc (ZMH.N: Quote, Profile, Research, Stock Buzz) spine stabilization device, questioning the company’s data but adding that the device holds promise.

The Food and Drug Administration’s advisory panel, in a 5-1 vote, said the company’s Dynesys Spinal System data were unclear and that some changes should have been made to its clinical trial. They also questioned how the device would hold up over time and expressed concern about possible breakage.

Zimmer’s device, a series of screws and flexible spacers that aim to help align and support the spine, is already approved for use in patients with back problems who undergo surgical fusion. The company is seeking the agency’s permission to market Dynesys for stand-alone use.

The company, which also sells another similar spinal device called Silhouette, has said the Dynesys device can allow a greater range of motion for patients than other products.

FDA officials will weigh the panel’s recommendation before later making a final approval decision.

Zimmer shares closed up 1.37 percent at $53.15 on the New York Stock Exchange. (Editing by Carol Bishopric)


Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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