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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