Baxter secures FDA clearance for Altapore Bioactive Bone Graft

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28/09/2018

Baxter International has obtained the US Food and Drug Administration (FDA) clearance for the use of the new Altapore Bioactive Bone Graft as an autograft extender in posterolateral spinal fusion.

The next-generation osteoconductive bone graft substitute already has clearance for application in orthopaedic surgeries of the extremities and pelvis.

The Altapore Bioactive Bone Graft has been developed to improve bone growth with optimised porosity to promote early vascularisation, which provides oxygen, nutrients and growth factors needed for bone formation.


“When used as an autograft extender in a pre-clinical posterolateral spinal fusion model, Altapore Bioactive Bone Graft demonstrated similar fusion rates to existing standard of care, iliac crest autograft, in spine surgical techniques.”

The graft’s porosity also enhances cellular activity by offering more surface area for cells to travel along its surface. This further promotes the development of new bone.

Altapore is said to feature precise handling characteristics that enable putty moulding into various shapes to address different surgical needs.

Baxter International Advanced Surgery business president Wil Boren said: “Providing surgeons with versatile tools like Altapore is critical to our commitment to partner with clinicians to advance healing in the operating room.

“With this clearance, more surgeons will have access to this innovative bone graft substitute as we look to improve outcomes across our entire portfolio of surgical products.”

When used as an autograft extender in a pre-clinical posterolateral spinal fusion model, Altapore Bioactive Bone Graft demonstrated similar fusion rates to existing standard of care, iliac crest autograft, in spine surgical techniques.

In addition to Altapore, Baxter’s osteobiologic surgical products portfolio includes Actifuse Shape, Actifuse MIS, Actifuse ABX and Actifuse Flow.

The company received the FDA clearance for Actifuse Flow earlier this month. This bone graft substitute is a pre-packaged delivery syringe used to accelerate bone growth.


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