Zimmer Biomet Gets FDA Approval for Scoliosis Treatment
August 16 2019 - 11:59AM
Dow Jones News
By Michael Dabaie
Zimmer Biomet Holdings Inc. (ZBH) said the U.S. Food and Drug
Administration approved its scoliosis treatment, The Tether.
The Tether provides a fusion-less alternative for young patients
requiring surgery, the company said. It uses a flexible cord,
rather than metal rods, to pull on the outside of a scoliosis curve
to initially straighten the spine, while the inside of the curve is
left free to grow. This growth modulation approach offers patients
an option to achieve a straighter spine without the limitations of
spinal fusion, Zimmer said.
As an emerging treatment for a select patient population, The
Tether is available through the FDA's humanitarian device exemption
pathway, Zimmer said.
Zimmer Biomet and the FDA are finalizing a new clinical study
for The Tether to monitor patient outcomes, the company said.
Zimmer shares were up 1.3% at $136.88.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
August 16, 2019 11:44 ET (15:44 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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