There has been a long PMA drought in orthopedics. This drought has been caused 100% by the FDA, not the device company innovators.
The Most Recent Example.
The first orthopedic panel meeting since 2018 was held with Active Implants. The purpose of the panel meeting was to review the NuSurface clinical data.
The Background. Active Implants sells a total meniscus replacement, called NuSurface, in Europe. I know a bit about NuSurface, because I worked there in R&D.
With a simple outpatient procedure, these lucky Europeans get an new medial meniscus and get their mobility and pain-free life back, without any restrictions. The NuSurface meniscus implant floats on the medial side of the knee, acts as a new shock absorber and spreads out the joints forces, thus alleviating the early OA pain.
In Europe, every day a NuSurface is implanted. This innovative product serves a critical role for early OA knee patients. NuSurface buys time for patients with early OA who are in the 40-60 year old range. These patients are too old for biologic treatments (cartilage repair) and too young for total knee replacements.
For almost 20 years, Active Implants has done everything that the FDA has...
