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.
More articles on devices:
26 spine devices receive FDA 510(k) clearance in January
Medtronic, Stryker, Zimmer Biomet, DePuy Synthes, Smith & Nephew: Who had the best 2015? 32 things to know
Cervical artificial disc replacement & lateral spine surgery: 6 things to know
