- Medtronic plc MDT announced the six months Results from the full cohort of the SPYRAL HTN-ON MED study.
- Subjects in the Symplicity Spyral Renal Denervation (RDN) System had a statistically significant and clinically meaningful reduction in systolic blood pressure (OSBP), a key secondary endpoint, compared to the sham control group.
- However, for the primary endpoint, RDN did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure (ABPM).
- The Medtronic device reduced systolic blood pressure by 6.5 points versus 4.5 in the sham procedure group.
- Renal denervation reduced this blood pressure measure by 9.9 points compared to a 4.9 point reduction in patients on the sham procedure, a statistically significant improvement.
- The company blamed the increased medication in the sham control group and the potential impact of COVID-19 on the clinical trial environment.
- The study met its primary safety endpoint with a low incidence of procedural and clinical adverse events.
- Although the study’s key efficacy goal was not met, Medtronic said it has completed its application to the FDA for approval of the device.
- Medtronic’s product is cleared for commercial use in more than 60 countries except the United States, Japan and Canada.
- Wall Street Journal writes that if the FDA approves the device, it could offer a new, non-drug treatment option for people with high blood pressure despite drug treatment. It could also become a top-selling product for Medtronic.
- Price promotion: MDT shares are down 5.31% to $81 during the premarket session last check Tuesday.
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