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WKN: 853815 / ISIN: US0718131099

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26.09.2018 15:18:10

Baxter: FDA Clears Altapore Bioactive Bone Graft In Posterolateral Spine Surgery

(RTTNews) - Baxter International Inc. (BAX) announced U.S. Food and Drug Administration or FDA clearance of Altapore Bioactive Bone Graft, a next-generation bioactive and osteoconductive bone graft substitute, for use as an autograft extender in posterolateral spinal fusion.

Altapore can now be used in posterolateral spinal fusion procedures when combined with autograft or autogenous bone marrow aspirate, as well as standalone bone graft substitute to fill bony voids or gaps in orthopedic applications.

Altapore had previously been cleared for use in orthopedic surgical procedures in the extremities and pelvis.

According to Baxter, 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.

In addition, Altapore's porosity increases cellular activity by providing more surface area for cells to travel along the surface of the graft, which promotes new bone formation.

Altapore bioactive bone graft is the latest addition to Baxter's osteobiologics portfolio of surgical products, which includes Actifuse Shape, Actifuse MIS, Actifuse ABX and Actifuse Flow.

Baxter received 510(k) clearance for the use of Altapore as an autograft extender in posterolateral spine in August 2018.

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 the end of this year.

Baxter intends to unveil Altapore at the 2018 North American Spine Society annual congress September 26 to 29 in Los Angeles.

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