VertiFlex's Superion device receives FDA PMA order: 4 takeaways

Spinal Tech

The FDA has issued a pre-market approval order for VertiFlex's Superion Interspinous Spacer System.

Here are four takeaways:

 

1. The Superion device is indicated for moderate lumbar spinal stenosis.

 

2. The approval order follows a February FDA Advisory Panel vote that Superion demonstrated safety, efficacy and a favorable risk benefit profile in an investigational device exemption trial.

 

3. Superion has been successfully implanted in more than 2,000 patients around the world and will soon be available in the United States.

 

4. Founded in 2005, VertiFlex is a privately held medical device company dedicated to developing minimally invasive solutions for the treatment of lumbar spinal stenosis.

 

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