Summary
Medtronic plc (MDT) has issued an 8-K filing to provide an update on its SPYRAL HTN-ON MED clinical study, which evaluates the Symplicity™ Renal Denervation System for hypertension. The company anticipates a prespecified interim data analysis by an independent monitoring board in late October. The outcome of this analysis, specifically whether the primary endpoint achieves statistical significance, will determine the next steps for the study. If the interim analysis shows statistical significance, enrollment in the ON MED study will be stopped, and the data will be prepared for presentation at the Transcatheter Cardiovascular Therapeutics Conference (TCT) in early November. However, due to the timing of the data analysis, the study will not be listed among TCT's late-breaking clinical trials. Medtronic is working with the Cardiovascular Research Foundation (CRF) to ensure the data is presented at TCT if the significance threshold is met. If the primary endpoint is not statistically significant at the interim look, the trial will continue to its full sample size.
Key Highlights
- 1Medtronic is providing an update on its SPYRAL HTN-ON MED clinical study for its Symplicity™ Renal Denervation System.
- 2An independent monitoring board will conduct a prespecified interim analysis of the study data in late October 2021.
- 3The primary outcome of the interim analysis will determine if the study's primary endpoint has achieved statistical significance.
- 4If statistically significant, the ON MED study enrollment will cease, and data will be prepared for presentation at the TCT conference in early November.
- 5The study will not be listed as a late-breaking trial at TCT due to the timing of the data analysis.
- 6Medtronic is coordinating with CRF to ensure potential presentation of positive results at TCT.
- 7If the primary endpoint is not statistically significant in the interim analysis, the study will continue enrollment to its full sample size.