Fitts Takes TranS1’s Regulatory Helm

Stephanie Fitts, Ph.D. is now vice president of Regulatory, Quality and Compliance for TranS1 Inc.

Fitts has nearly 20 years of medical device experience having worked in the above mentioned areas. For the past nine years, she worked at Stryker Orthopaedics.

During her time at Stryker, she served in multiple leadership positions, including most recently as senior director, Regulatory Affairs and Compliance and, from 2008 until 2011, as director, Regulatory Affairs and Compliance. Prior to her time at Stryker, she served as senior clinical program manager at Medtronic, Inc. from 2000 until 2003. Prior to that, Fitts held positions at Cardiac Rhythm Management and Telectronics Pacing Systems.

Fitts holds a B.S. degree in Engineering Science from the University of Virginia, and a Ph.D. in Bioengineering from Pennsylvania State University.

TranS1 has served as a poster child for navigating the regulatory and reimbursement pathways for a novel procedure.

This past March we reported that the company finally convinced the American Medical Association to include its unique presacral lumbar interbody fusion procedure into existing CPT (Current Procedural Terminology) codes.

There had been a lack of consistent reimbursement for the codes the procedure had been trying to squeeze into. In theory, the reimbursement pathway should be a little clearer. Fitts is joining TranS1, no doubt, to help clear up reimbursement issues and convince more payers of the merits of the science to cover the procedure. The company has five papers accepted for publication this year. Surgeon training efforts have also expanded as the company announced the opening of a new training center in Raleigh, North Carolina, in February.

TranS1 currently markets the AxiaLIF family of products for single- and two-level lumbar fusions, the VEO lateral access and interbody fusion system, and the Vectre and Avatar posterior fixation systems for lumbar fixation supplemental to AxiaLIF fusion.