FDA expands safety claim for Zimmer Biomet's Gel-One Cross-linked Hyaluronate — 4 notes

Spinal Tech

The FDA's safety claim for Zimmer's injection indicates the product is safe to use in repeat treatments for knee osteoarthritis patients.

Here are four notes:

 

1. Gel-One Cross-linked Hyaluronate is single-injection viscosupplement for the knee joint.

 

2. The injection is intended for knee osteoarthritis patients who have not responded adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs or simple analgesics.

 

3. Zimmer's product is the first low-volume viscosupplement available in a single-injection formulation for treating knee osteoarthritis.

 

4. To complete the treatment course, Gel-One Cross-linked Hyaluronate requires a single 3mL injection.

 

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