Thursday, September 27, 2018
Baxter International Inc., a global leader in advancing surgical innovation, today announced U.S. Food and Drug Administration (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 had previously been cleared for use in orthopedic surgical procedures in the extremities and pelvis.
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. ALTAPORE’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, ALTAPORE’s unique chemistry contains 0.8 percent silicon by weight, which was shown to be optimal for bone formation in preclinical studies.
“ALTAPORE utilizes Baxter’s proprietary silicate-substituted technology and has an enhanced porosity that provides for earlier vascularization, increased cellular activity and improved volume of new bone growth. I’ve had a good experience with ACTIFUSE bone graft substitute, and am looking forward to taking advantage of the novel characteristics of ALTAPORE for my patients,” said Roger Härtl, M.D., professor of Neurological Surgery, director of Spinal Surgery, and director of the Weill Cornell Medicine Center for Comprehensive Spine Care in New York.
ALTAPORE has been formulated to meet surgeons’ needs, as it is easy to store, handle and implant. Its precise handling characteristics allow the putty to be molded into multiple shapes to adapt to various surgical needs. Additionally, in a pre-clinical posterolateral spinal fusion model, ALTAPORE used as an autograft extender exhibited similar fusion rates to iliac crest autograft, which is considered the current standard of care in spine surgical techniques. The iliac crest is an area of the pelvis commonly used for acquiring autogenous bone graft.
“Providing surgeons with versatile tools like ALTAPORE is critical to our commitment to partner with clinicians to advance healing in the operating room,” said Wil Boren, president of Baxter’s Advanced Surgery business. “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.”
ALTAPORE Bioactive Bone Graft is the latest addition to Baxter’s growing 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 United States by year-end. Baxter intends to unveil ALTAPORE at the 2018 North American Spine Society annual congress Sept. 26-29 in Los Angeles.
