Baxter (NYSE:BAX) said today it won FDA clearance for its Altapore bioactive bone graft, indicated for use as an autograft extender in posterolateral spinal fusion.
The Altapore bone graft is designed to enhance bone growth and features improved porosity which the company said promotes earlier vascularization and can improve the bone formation process. Baxter said that the Altapore’s porosity is also intended to increase cellular activity by providing more surface areas for cells to travel along the surface of the graft to promote new bone formation.
“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,” Dr. Roger Härtl of New York’s Weill Cornell Medicine Center for Comprehensive Spine Care said in a prepared statement.
The Deerfield, Ill.-based company said that the Altapore bone graft had been previously cleared for use in orthopedic surgical procedures in the extremities and pelvis.
“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,” Baxter advanced surgery business prez Wil Boren said in a press release.
Baxter said that it has begun packaging inventories with new FDA-approved labeling, and expects to start selling it in the US by the end of the year.
Earlier this month, Baxter said that it won FDA clearance for its Actifuse Flow bone graft substitute, indicated for use in a variety of orthopedic surgical procedures.
