FDA advisory committee rejects bone growth stimulator reclassification petition
Members cite too many holes in available research and want more clinical trials involving diverse populations.
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Citing insufficient data to establish special controls, the FDA Orthopedic and Rehabilitation Devices Advisory Committee voted 4-2 on June 2 against downclassifying noninvasive bone growth simulators from Class III to Class II devices.
RS Medical petitioned for the reclassification, which would have included three pulsed electromagnetic field (PEMF) and three capacitive coupling (CC) devices indicated for nonunion fractures and adjunct lumbar spine fusions. The company argued that PEMF and CC devices share the same purpose, and that the technologys risks could be minimized with controls.
We believe that the noninvasive bone growth stimulator does not present an unreasonable risk to health and that the general and special controls will provide a reasonable assurance of both device safety and effectiveness, said William Carroll, RS Medicals vice president of research and development. Thus, in our opinion, non-invasive bone growth stimulators should be placed in Class II, he added.
The company cited 35 clinical studies on fracture nonunion and eight lumbar spine studies using PEMF and CC devices. However, advisory committee members contended that the studies provided inadequate data, noting that some studies were outdated and had low levels of evidence.
Meta-analysis for a clinical series is inadequate. The level of evidence for all of the clinical papers submitted is, at best, poor. There are too many holes and theres inadequate clinical data, said committee member Sanjiv H. Naidu, MD, PhD.
Other committee members called for additional clinical trials that included patients with comorbidities. However, issues surrounding device propriety made it difficult for the committee to detail the waveform parameters necessary for such future studies.
It is my opinion ... that the extensive amount of clinical data that we would like to see as a panel cannot be fully specified in the few minutes here, said John S. Kirkpatrick, MD, committee chairman. [It] is complex, dependent on special populations and dependent on the specific devices, and would require negotiation on issues of what specific outcomes need to be addressed, he added.
Committee member Jay D. Mabrey, MD, also questioned the relationship between similar waveform parameters and their results.
I believe what is being asked of the panel today ... is that we accept the fact that a parameter, or quote parameters, are enough to not only characterize an individual device but to assure the public that it is as effective as existing devices, he said. In short, output does not equal effectiveness, and I would argue that an ineffective device to a patient with a painful malunion constitutes a substantial impingement upon that patients overall health.