FDA Clears Baxter Altapore Bioactive Bone Graft in Posterolateral Spine Surgery
September 26 2018 - 10:06AM
Dow Jones News
By Michael Dabaie
The U.S. Food and Drug Administration cleared Baxter
International Inc.'s (BAX) Altapore Bioactive Bone Graft for use as
an autograft extender in posterolateral spinal fusion.
Altapore had previously been cleared for use in orthopedic
surgical procedures in the extremities and pelvis, the hospital and
surgical products company said.
Altapore is designed to enhance bone growth with optimized
porosity that promotes earlier vascularization, which plays a
central role in the bone formation process by providing oxygen,
nutrients, and growth factors critical for bone development, Baxter
said.
Baxter received 510(k) clearance for the use of Altapore as an
autograft extender in posterolateral spine in August. The company
has started the process of packaging inventories carrying the new
FDA-approved labeling and expects to start selling product in the
U.S. by year end.
Baxter shares were up 0.2% to $77.62 in early trading.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
September 26, 2018 09:51 ET (13:51 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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