Journal Publishes Clinical Studies for Two Baxano Surgical Devices

The Journal of Spinal Disorders and Techniques (JSDT) has published two clinical studies focused on two of Baxano Surgical Inc.’s core technologies: the AxiaLIF (lumbar interbody fusion) Plus presacral access and interbody fusion system and the iO-Flex minimally invasive decompression instrument.

“Having two of our core technologies represented in the December issue of JSDT is certainly an honor,” said Ken Reali, president and CEO, Baxano Surgical. “This positive clinical data on Baxano Surgical’s unique technologies adds to our growing compendium of peer-reviewed publications and validates our continued efforts in expanding our clinical strategy to advance our minimally invasive spine implants and instruments.”

The first paper describes a head-to-head study by two independent spine surgeons comparing AxiaLIF Plus to ALIF in 96 total patients. AxiaLIF Plus 1-Level (L5-S1) with pedicular fixation was compared to ALIF (L5-S1) with pedicular fixation and was authored by Peter G. Whang, M.D. All patients had two year or greater follow up with thin slice CT (computed tomography) scans. Thin slice scans offer higher image resolution than regular CT scans.

In the surgeons’ combined review, AxiaLIF Plus demonstrated higher fusion rates than ALIF (anterior LIF), although the difference was not statistically significant. Further, the AxiaLIF cohort experienced no serious adverse events, compared with the ALIF cohort, in which one serious adverse event was reported.

“Based upon our clinical and radiographic review, the safety and efficacy of the AxiaLIF procedure appears to be comparable to that of ALIF when used in conjunction with posterior instrumentation, suggesting that this less invasive technique is a viable method for achieving an interbody fusion across the lumbosacral junction,” said Peter Whang, associate professor of orthopedics and rehabilitation at Yale University, New Haven, Conn.

The second paper describes data from a prospective, observational study on 59 subjects who underwent a facet-sparing decompression using the iO-Flex minimally invasive decompression instrument for lumbar spinal stenosis. Operative technique, operative data and surgical adverse events were evaluated. With the iO-Flex instrument there were no device-related operative complications. A subset of patients were evaluated radiographically using CT scans, access to the lateral recess and foramen was achieved with removal of less than 6 percent of the superior facet cross-sectional area. The study was authored by Lawrence M. Dickinson, M.D.

“We have shown that the iO-Flex instrument coupled with standard surgical technique comprehensively decompresses the central canal, lateral recess and far lateral foramen while preserving the facet anatomy, thus limiting the cause of future instability,” said Dickinson, from Pacific Brain and Spine Medical Group in Castro Valley, Calif. “Symptom resolution, including back pain has been very impressive. The fact that iO-Flex preserves the posterior anatomy should result in a much lower incidence of instability and reoperation rate.”

Baxano Surgical is based in Raleigh, N.C., and focuses on minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region.