FDA Orthopedic

FDA clears new Baxter bone graft substitute

Baxter (NYSE:BAX) announced today that it received FDA clearance for its Altapore Shape bioactive bone graft for bone growth and fusion.

Deerfield, Ill.-based Baxter’s Altapore Shape is its latest addition to its bone graft substitute product line, designed to enhance bone growth and aid in achieving fusion, leading to reduced pain and other improved clinical outcomes for patients, according to a news release.

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 caused by trauma, including those within the pelvis, extremities and the posterolateral spine. The bone graft resorbs and is replaced with bone during the healing process, enhancing bone growth with optimized porosity that promotes earlier vascularization.

Baxter offers the system in four configurations, with three cylinders of different sizes — 1.6 ml, 2.6 ml and 8 ml — with one 15.8 ml strip to aid surgeons in molding the product to fit multiple needs. Altapore Shape features Baxter’s proprietary silicate-substituted technology shown to be optimal for bone formation, the company said.

“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,” Baxter advanced surgery business president Wil Boren said in the news release.

Original Article: (https://www.massdevice.com/fda-clears-new-baxter-bone-graft-substitute/)

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