Renal Denervation, HTN-3 Fails to Reach its Primary Efficacy Endpoint
Published date : 10 January 2014
Article date : 10 January 2014
The trial has met its primary safety endpoint and no specific action is required for patients who have been treated.
Medtronic intends to:
1. Suspend enrollment in SYMPLICITY HTN-4 US, HTN Japan and HTN India.
2. Inform trial sites, investigators, customers and regulatory bodies of the findings.
3. Continue to ensure access to the Symplicity system at the discretion of physicians where it is regulatory approved.
4. Continue with the post market surveillance registry.