A new report from MD+DI Online article examines whether the axial lumbar interbody fusion device for the presacaral area is gaining new life. The system achieved FDA clearance in 2005 but CMS and other private insurers did not grant coverage. The device, granting access to L5-S1, floundered as a result.
Here are six key notes on the transformation since it initially hit the market:
1. In 2011, the U.S. Department of Justice subpoenaed TranS1, the company responsible for AxiaLIF, for encouraging incorrect diagnosis/procedure codes that allegedly allowed some surgeons to receive kickbacks. The company settled the case for $6 million without admitting wrongdoing.
2. Baxano Surgical merged with TranS1 in 2013, the same year Medicare began covering the procedure.
3. Baxano filed for Chapter 11 bankruptcy protection late in 2014 and was out of business mid-2015. But attorney Jeffrey Schell purchased AxiaLIF for $860,000. Quandary Medical purcahsed AxiaLIF and the TranS1 brand in February 2015 and started marketing for the product then.
4. The company is now focused on supporting AxiaLIF with a sales force and network to spread the device. Currently, there is a 20-person engineering support team and a 50-member salesperson team.
5. The technology is now distributed in the United States and Europe; TranS1 is working on making it available in China and Japan as well.
6. Last year the company filed more than 25 patent applications and plans to continue “very aggressive” research and development. A study from 2014 shows AxiaLIF costs $3,500 less than other spinal fusion procedures on average and can lead to advantages like lower hospital readmission and quicker return-to-work.
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