FDA approves expandable implant for spinal fusion surgery


Expanding Orthopedics' FLXfit implant--Courtesy of Expanding Orthopedics

The FDA has cleared Expanding Orthopedics' FLXfit implant for spinal fusion surgery, the Israeli company announced July 21.

Expanding Orthopedics says it is the world's first 3D expandable interbody cage, meaning the device is placed between two vertebrae to encourage bone growth in the area between them. The devices are used to treat degenerative disk disease, according to the University of Maryland Medical Center.

A video on the company's website demonstrates the expansion. Following implantation, the surgeon uses a screwdriver-like device to initiate the implant's height expansion, which increases the area between the two vertebrae and corrects the angle of the spine, according to the company.

"This unique and patented technology combines minimal invasive access, maximum footprint support and large bone graft chamber with unique lordotic expansion for sagittal balance correction," said Ofer Bokobza, CEO of Expanding Orthopedics, in a statement. He added that interbody cages have established reimbursement codes and the market for them is growing at a compounded annual growth rate of 30%.

The company also sells the CE marked XPED Expandable Pedicle Screw System, which also expands within the body following implantation.

The clearance comes as public and private insurers are significantly tightening reimbursement for the procedure, whose prevalence increased 70% between 2001 from 2011, or from 288,000 to 488,000 procedures per year. For example, Becker's Spine Review reported Blue Cross Blue Shield of Kansas now requires patients to try nonsurgical options prior to approving procedures, and says the trend is nationwide. Changes to CPT coding practices are also lowering reimbursement, both public and private, the article said.

As a result of this payer skepticism, GlobalData analyst Joseph Gregory recently estimated that the volume of procedures will increase at a compounded annual growth rate of 5% through 2020, instead of the previous 10%, but that still represents a 40% increase from 2013 to 2020. He said that by 2020 the spinal fusion market will be worth $4.4 billion in the U.S., $684 million in Japan and $665 million in China.

- read the release
- read the Becker's Spine Review article

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