FDA Clears Altapore Shape Bioactive Bone Graft

Baxter International Inc. has announced U.S. Food and Drug Administration (FDA) clearance of Altapore Shape Bioactive Bone Graft, the latest addition to the company’s bone graft substitute product line. Altapore Shape is designed to enhance bone growth and help achieve fusion, which can lead to reduced pain and other improved clinical outcomes for patients.
 
“We are introducing this new format in our Altapore product line to give surgeons versatile tools as they work to advance the art of healing and improve clinical outcomes in the operating room,” said Wil Boren, president of Baxter’s Advanced Surgery business.
 
Clinical Study
A 2019 prospective, open-label, non-randomized clinical study evaluated 102 patients with degenerative disc disease, spondylolisthesis and spinal stenosis undergoing instrumented posterolateral fusion (PLF) procedures per protocol using Altapore Bioactive Bone Graft. The study found that successful fusion was achieved in 86.3% of those patients at month 12. 
 
Altapore Bioactive Bone Graft and Altapore Shape share similar properties and handling characteristics, and the study indirectly supported the FDA submission for Altapore Shape. At month 12, patients reported a 60% improvement in total pain from baseline using the Visual Analog Scale and a 48% improvement in disability from baseline using the Oswestry Disability Index.
 
Patients also reported an improved quality of life post-surgery, and more than 50% of patients achieved neurological success, defined as maintaining or improving functionality in five parameters including motor, sensory, reflex, straight leg raise, and femoral stretch. The study design did not include a comparator treatment, so no direct comparison to other treatments can be made.¹
 
Altapore Shape is used as a standalone bone graft substitute or as an autograft extender to fill bony voids or gaps in the skeletal system, including in the pelvis, extremities and posterolateral spine, that are surgically created or result from trauma. Altapore Shape resorbs and is replaced with bone during the healing process and comes in four configurations – three cylinders of differing sizes (1.6 ml, 2.6 ml and 8 ml) and one strip (15.8 ml) – to aid surgeons in molding the product to fit various surgical needs.²
 
The entire Altapore product line is designed to enhance bone growth with optimized porosity that promotes earlier vascularization. Vascularization plays a central role in the bone formation process by providing oxygen, nutrients and growth factors critical for bone development.³ 
 
Altapore Shape’s porosity also increases cellular activity by providing more surface area for cells to travel along the surface of the graft, which promotes new bone formation. Additionally, the product features Baxter’s proprietary silicate-substituted technology, which contains 0.8% silicon by weight and was shown to be optimal for bone formation in preclinical studies.⁴ Both Altapore Shape and Altapore consist of identical silicate-substituted calcium phosphate granules, and the differences in absorbable carrier phase do not alter the intended therapeutic use of the devices.
 
References:
¹ Bolger Ciaran and Jones, D. (2019, 7). Evaluation of an increased strut porosity silicate-substituted calcium phosphate, SiCaP EP, as a synthetic bone graft substitute in spinal fusion surgery: a prospective, open-label study. European Spine Journal, 28(7), 1733-1742.
² Altapore Shape Bioactive Bone Graft Instructions for Use – Important Product Information
³ Campion CR, Chandler C, Buckland T, Hing K. Increasing strut porosity in silicate-substituted calcium-phosphate bone graft substitutes enhances osteogenesis. J Biomat Mater Res Part B: Appl Biomater. 2011;97B:245-254.
⁴ Hing K et al. Effect of silicon level on rate, quality and progression of bone healing within silicate substituted porous hydroxyapatite scaffolds. Biomaterials. 2006;27(29):5014-5026.