Medtronic keeps renal denervation data coming

As cardiologists wait for the pivotal US trial of Medtronic’s Symplicity Spyral to report next year, data from two smaller studies hint at the renal denervation device’s potential as a therapy for hypertension. Results from an investigator-sponsored, Medtronic-funded trial, presented today at the EuroPCR meeting in Paris, found that 19% of patients treated with denervation developed subclinical atrial fibrillation, compared with 47% of those who received a sham procedure. The trial, in 80 high-risk patients with hypertensive heart disease who were at risk of atrial fibrillation and cardiovascular death, might be a very early step towards expanding the Symplicity Spyral’s addressable population. To this end Medtronic is conducting the 70-patient Symplicity AF study of the device in patients with paroxysmal and persistent atrial fibrillation; results are expected this summer. And data from the Global Symplicity Registry, tracking patients treated with the device since its approval in Europe in 2013, led to reductions in office and 24-hour ambulatory blood pressure of 16.5mmHg and 8.9mmHg respectively at three years post-treatment. Medtronic describes these data, which come from 2,300 patients, as “significant and clinically meaningful”.

Medtronic's US renal denervation trials
Device Study Enrolment Primary efficacy endpoint Status Trial ID
Symplicity Symplicity-HTN3 535 Change in office systolic BP at 6mth First US pivotal trial; failed Jan 2014 NCT01418261
Symplicity Spyral Spyral HTN-Off Med 170 Change in systolic 24hr BP at 3 yr 3mth interim data reported Aug 2017; full data end 2018 NCT02439749
Symplicity Spyral Spyral HTN-On Med 106 Change in systolic 24hr BP at 3 yr 3mth interim data expected May 2018; full data 2021 NCT02439775
Symplicity Spyral Spyral HTN Pivotal Trial 433 Change in 24hr BP at 3mth Full data expected 2020 NCT02439749
Symplicity Spyral Symplicity-AF 245 Freedom from either AF lasting 30 sec or more, or intervention for AF Full data expected Jul 2019 NCT02064764
BP=blood pressure. AF=atrial fibrillation. Source: EvaluateMedTech and Clinicaltrials.gov.

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