Amedica has submitted 24-month clinical outcomes data from its CASCADE study to the FDA.
Here are six observations:
1. The blinded, randomized clinical trial compared outcomes of cervical fusion between Amedica's composite silicon nitride devices manufactured with a core of cancellous structured ceramic to the existing standard: PEEK spacers filled with bone autograft.
2. The CASCADE study divided the participants into two groups — one treated with Amedica's composite silicon nitride devices and the other with PEEK.
3. The study showed comparable clinical and radiographic performance between porous silicon nitride and bone autograft.
4. The FDA previously confirmed that it would review the product as a medical device.
5. The federal agency has 90 days in which to either clear the Class II device for commercial distribution or to seek additional information.
6. Amedica is a medical technology company focused on the development and application of medical-grade silicon nitride ceramics.