- Medtronic plc MDT announced the six-month results from the full cohort of the SPYRAL HTN-ON MED trial.
- Subjects in the Symplicity Spyral Renal Denervation (RDN) System had a statistically significant and clinically meaningful reduction in office-based systolic blood pressure (OSBP), a key secondary endpoint, compared to the sham control group.
- However, in the primary endpoint, RDN did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure (ABPM).
- Medtronic’s device cut systolic blood pressure by 6.5 points vs. 4.5 in the sham procedure group.
- Renal denervation reduced this measure of blood pressure by 9.9 points versus a 4.9-point reduction for patients in the sham procedure, a statistically significant improvement.
- The company blamed the increased medications in the sham control group and the potential COVID-19 impacts on the clinical trial environment.
- The study met its primary safety endpoint, with a low incidence of procedure-related and clinical adverse events.
- Despite falling short of the study’s main efficacy goal, Medtronic said it had completed its application to the FDA for approval of the device.
- Medtronic’s product is approved for commercial use in more than 60 countries but not in the U.S., Japan, and Canada.
- Wall Street Journal writes that if the FDA approves the device, it could offer a new, nonmedication treatment option for people with high blood pressure despite drug treatment. It could also be a big-selling product for Medtronic.
- Price Action: MDT shares are down 5.31% at $81 during the premarket session on the last check Tuesday.
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