- Medtronic's renal denervation system Symplicity Spyral has reduced blood pressure out to three years in a clinical trial, leaving analysts incrementally positive ahead of upcoming pivotal data from another study.
- Researchers, writing in The Lancet, reported an 18.7 mmHg drop in 24-hour systolic ambulatory blood pressure at three years, compared with an 8.6 mmHg decline in the sham control group. Analysts at Stifel said the data underscores Spyral's real-world efficacy and patient benefit.
- However, analysts at J.P. Morgan cautioned against using the data as a guide for the upcoming pivotal data that will shape Medtronic's bid to build a $2 billion business by 2030. Spyral failed to outperform the sham treatment in the pivotal trial at an interim analysis last year.
Medtronic and ReCor Medical separately have rebuilt confidence in the renal denervation opportunity in recent years with results that contradict the findings of a key study that failed in 2014. SPYRAL HTN-ON MED, the Medtronic study that delivered three-year data this week, has contributed to the rehabilitation of renal denervation in the treatment of uncontrolled hypertension.
The latest update, which was simultaneously shared at the American College of Cardiology's 71st Annual Scientific Session and in The Lancet, covers what happened after a six-month analysis that found the intervention outperformed the control. After six months, physicians were able to change the regimens taken by their patients, leading to a higher medication burden in the control arm. Those changes may have contributed to the failure of Spyral to outperform the control at the one-year analysis.
Spyral performed better after three years, beating the 24-hour systolic ambulatory blood pressure of the control arm by 10 mmHg. The intervention also outperformed control in terms of office systolic blood pressure, posting a 20.9 mmHg reduction compared with a 12.5 mmHg decline in the sham arm. Analysts at J.P. Morgan welcomed the findings.
"The statistically significant difference between the two groups at 36 months points to the sustained benefit of the treatment and potential superiority to medications with short half-lives and/or patient non-adherence," the analysts wrote in a note to investors.
However, the J.P. Morgan analysts and their peers at Stifel noted the limitations of the data. The team at Stifel cited the relatively small size of the study, which enrolled 80 patients, and the fact that participants could cross over to the treatment cohort from the sham arm as reasons for caution.
The J.P. Morgan analysts framed the results in light of the upcoming readout from a pivotal trial, which they expect later this year. All that is publicly known about the pivotal results is they fell short of the bar needed for the trial to stop at the interim analysis. That knowledge was enough for the J.P. Morgan analysts to draw a distinction between the pivotal trial and pre-pivotal SPYRAL HTN-ON MED.
"The only thing we know is that the data didn't look similar to the pre-pivotal, otherwise it would've read out," the analysts wrote.
Although the wait for pivotal data goes on, both doctors who the Stifel analysts spoke to think Medtronic has done enough to secure FDA approval provided the next readout is free from safety surprises. The analysts expect Medtronic to use its SPYRAL HTN-ON MED data in the submission, although the doctors are uncertain how meaningful an impact it will have on the FDA vote.