2nd UPDATE: FDA Orders Studies On Spinal Devices
(Adds comment from DePuy Spine, Medtronic spokeswomen in sixth and seventh
paragraphs.)
By Jon Kamp
Of DOW JONES NEWSWIRES
The U.S. Food and Drug Administration said Monday that companies making or
hoping to sell so-called dynamic-stabilization systems for spinal surgery must
run studies to collect data on "a number of potential safety issues."
The list of companies includes units of Johnson & Johnson (JNJ) and Zimmer
Holdings Inc. (ZMH). There isn't enough clinical data to determine whether these
systems provide enough spinal stability to allow for complete fusion, the FDA
said in a release, since system components may loosen, bend or break over time.
"If fusion does not occur, a patient's condition could worsen and possibly
require additional surgical procedures," the agency said.
It is requiring post-market studies, which are for already approved devices,
to review these potential risks. The agency also is asking manufacturers of new
systems or components to submit clinical information for agency review before
these products are marketed.
These studies must address the fusion rate for dynamic-stabilization systems
compared with traditional systems, the FDA said. The studies also must include
information on serious events and subsequent surgeries linked to these devices,
plus reasons for failure.
A spokeswoman for J&J's DePuy Spine unit said the company had just received
the FDA's notification and is evaluating how to best comply with this new
requirement.
A spokesman for Zimmer, which doesn't have this type of product approved for
fusion but has submitted an application, said the company didn't have a comment
late Monday. A spokeswoman for medical-devices heavyweight Medtronic Inc. (MDT),
which has a big spine business, said the company will work with the FDA in
complying with the request.
While older, rigid stabilization systems immobilize spinal segments, the newer
systems - the first was approved 12 years ago - have design features that allow
for some flexibility while still facilitating fusion.
The FDA said it's not recommending changes regarding the use of dynamic-
stabilization systems until it collects and reviews clinical data to better
understand how these devices are being used. With that information, the agency
said it will consider whether changes to product labels or additional testing
requirements are needed.
The FDA said patients who have or are considering implantation of one of these
systems should consult with their health-care practitioner.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728; jon.kamp@dowjones.com
(END) Dow Jones Newswires
10-05-091954ET
Copyright (c) 2009 Dow Jones & Company, Inc.
|