Why Medtronic (MDT) Stock Is Falling Today - Medtronic (NYSE:MDT)

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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Medtronic Shares Fall As Blood Pressure Reduction Device Fails On Primary Goal