Baxter International has secured approval from the US Food and Drug Administration (FDA) for its Altapore bioactive bone graft for use in posterolateral spine surgery.
Altapore is a next-generation bioactive and osteoconductive bone graft substitute developed for use as an autograft extender in posterolateral spinal fusion.
Earlier, Altapore was approved for use in orthopedic surgical procedures in the extremities and pelvis.
The company has designed Altapore to enhance bone growth with optimized porosity, enabling to promote earlier vascularization.
The bone graft substitute plays a significant role in the bone formation process by offering oxygen, nutrients and growth factors necessary for bone development.
Altapore’s porosity will also enhance cellular activity by offering more surface area for cells to travel along the surface of the graft, allowing to promote new bone formation.
The new bone graft substitute’s unique chemistry is said to contain 0.8% silicon by weight, which was demonstrated to be optimal for bone formation in preclinical studies.
Formulated to meet surgeons’ requirements, Altapore can be easily stored, handled and implanted.
The bone graft is provided with accurate handling characteristics, which will enable the putty to be molded into multiple shapes to adapt to various surgical needs.
In a pre-clinical posterolateral spinal fusion model, the bone graft is used as an autograft extender, which showed similar fusion rates to iliac crest autograft. The iliac crest is an area of the pelvis generally used for acquiring autogenous bone graft.
The company’s osteobiologics surgical products include Actifuse Shape, Actifuse MIS, Actifuse ABX and Actifuse Flow, in addition to Altapore.
Baxter has already commenced the process of packaging inventories carrying the new FDA-approved labeling and plans to begin marketing product by the end of this year.
Baxter’s 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.”