FDA expands use of Baxter bone graft to spinal fusion

Dive Brief:

The FDA has cleared Baxter’s bone graft substitute Altapore for use in posterolateral spinal fusion procedures.
Altapore is designed to support bone growth and thereby help patients recover after undergoing orthopedic surgical procedures.
Baxter received the 510(k) clearance on the strength of a submission that compared Altapore to Medtronic’s Mastergraft Putty.

Dive Insight:

Many of the big names in medtech are competing with Baxter for the bone graft substitute piece of the advanced surgery market. Medtronic, Johnson & Johnson, Stryker and Zimmer all have bone graft products.

The introduction of the products will open up a new sales opportunity for Baxter in a growing, albeit small, part of its business. In the second quarter, sales at Baxter’s advanced surgery unit increased 15%, accelerating the upward trend seen over the first three months of the year. Baxter expects the market for advanced surgery products such as Altapore to grow by up to 5% a year until 2023.

Surgeons can resolve bone defects by taking bone from one part of the body and using it to fix the damaged area. However, there are limits to how much bone surgeons can safely harvest. This limitation has driven decades of research into bone substitutes. Polymers, ceramics and composites have emerged from these efforts, culminating in orthobiologic devices that aid bone regeneration.

Baxter bought itself a position at the front of the emerging orthobiologic field in 2010 when it paid $240 million upfront, plus up to $90 million in milestones, for ApaTech. Four years later, Baxter received clearance to market Altapore for use in the extremities and pelvis.

Now, the FDA has given surgeons the green light to use Altapore in spinal fusion procedures. Baxter received the clearance after comparing Altapore to Medtronic’s Mastergraft Putty in 182 rabbits that underwent posterolateral fusion of the spine. Baxter reported no complications or deaths related to Altapore in the 12 weeks following the procedures.

Baxter is now gearing up to bring Altapore to market in the new indication. Production of packs carrying the new labeling is underway and Baxter expects to start shipping them to customers by the end of the year.