Safety and effectiveness of LATERA,

Data just published from the prospective, multicenter, single-blinded, randomized controlled trial (RCT) demonstrates the safety and effectiveness of LATERA for patients in whom dynamic NVC is a main contributor to their NAO. The LATERA implant significantly improves patients’ NAO symptoms when compared with a sham, demonstrating the implant is superior.

Key findings from the study include:

• LATERA works. The responder rate is significantly higher for the treatment arm (82.5%, 52/63) compared to the sham control arm (54.7%, 35/64), demonstrating the treatment arm is superior to the sham control arm (p = 0.001). It is also notable that the treatment arm exhibited improvement from 1 to 3 months, whereas the sham control arm showed worsening outcomes, suggesting that over time there is an increasing benefit of the implant.
• Significant NAO symptom improvement. The implant procedure showed significantly more improvement in NAO scores than the sham procedure.
• At 3 months after treatment, the treatment arm had a significantly greater reduction in the mean NOSE score compared with the sham arm (–42.4 ± 23.4 vs –22.7 ± 27.9, p < 0.0001)
• At 3 months after treatment, the treatment arm had a significantly greater reduction in the mean VAS score than the sham control arm (–39.0 ± 29.7 vs –13.3 ± 30.0, p < 0.0001)

Request the article