On Feb. 19, the FDA's orthopedic and rehabilitation devices advisory panel voted against the recommendation of Medtronic's Diam spinal stabilization implant, according to Fierce Medical Devices.
Here are five highlights:
1. The panel rejected the device due to a lack of rigorous clinical trial data.
2. Although the FDA often adheres to panel recommendations, it does not have to follow the advice.
3. The Diam device is intended for patients with moderate low back pain secondary to single-level symptomatic lumbar degenerative disc disease.
4. The panel members felt clinical data did not effectively prove the device's safety, efficacy and risk-reward profile.
5. The Diam device received the CE mark more than a decade ago.