Benzinga - by Vandana Singh, Benzinga Editor.
The FDA Circulatory System Devices Panel vote was closely divided on the benefit/risk profile of Medtronic Plc's (NYSE: MDT) device (tied at 6-6 and one abstention), with the panel chair breaking the tie, resulting in a final 6-7 vote, recommending against the approval of the blood pressure treatment device, saying associated do not outweigh the benefits.
The committee raised multiple eyebrows on the MDT HTN-ON MED trial's results. The trial's failure to meet its primary efficacy endpoint is a critical point of contention.
This certainly didn't bolster confidence in the hypertension treatment device. Moreover, the marginal benefit from RDN in blood pressure reduction has left many unconvinced of its clinical benefit.
A closer look at the data also reveals significant variability between patients.
This inconsistency raises questions about Symplicity Spyral's widespread applicability and predictability.
Another point brought up during the discussions was the seeming incongruence between Medtronic's proposed indications for use and the trial designs.
Given the unfavorable vote, the pathway to FDA approval for Symplicity Spyral appears murky. Medtronic's journey with RDN hasn't been smooth.
Their acquisition of Ardian in 2011 and the subsequent failure of the SYMPLICITY HTN-3 trial in 2014 are testament to the challenges faced, Needham writes. The analysts maintain the Hold rating for the stock.
Considering the extensive investments and the disappointments along the way, it wouldn't be surprising if MDT decides to step away from RDN if this approval doesn't come through.
Price Action: MDT shares are down 2.95% at $81.20 on the last check Thursday.
Latest Ratings for MDT
| Feb 2022 | Credit Suisse | Maintains | Outperform | |
| Feb 2022 | Needham | Maintains | Buy | |
| Feb 2022 | Raymond James | Maintains | Outperform |
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