A clinical trial has linked Medtronic's Symplicity renal denervation system to a reduced occurrence of subclinical atrial fibrillation in a subset of high-risk patients.
Renal denervation is intended to treat a possible cause of hypertension and arrhythmias by decreasing the activity of nerves in the kidney, but mixed clinical data have caused interest in the approach to wax and wane.
The results presented this week provide a small boost to the field ahead of readouts from trials sponsored by Medtronic and rivals including ReCor Medical.
Symplicity and the wider renal denervation field hit a low point in 2014 when a large clinical trial of Medtronic's device in patients with hypertension missed its primary endpoint. Since then, Medtronic and ReCor have generated encouraging results, raising expectations ahead of readouts from pivotal trials.
Medtronic arrived at the EuroPCR meeting in Paris armed with data that mark another small step in the turnaround of the renal denervation sector.
Some of the data shared by Medtronic was generated in an investigator-sponsored, company-funded clinical trial of 80 high-risk patients with hypertensive heart disease. The trial found 19% of subjects treated with Medtronic's Symplicity developed subclinical atrial fibrillation as compared to 47% of patients in the treatment control arm.
Medtronic also used EuroPCR to share updated data from its Global Symplicity Registry, which now has three years of follow-up for more than 2,300 patients. The three-year data show people treated with Symplicity have experienced reductions in office and ambulatory blood pressure of 16.5mmHg and 8.9mmHg, respectively. Medtronic called the declines "significant and clinically meaningful."
The results offer some encouragement but the bigger tests of Symplicity are still to come. Medtronic is testing the device in two randomized, sham-controlled trials of patients with uncontrolled blood pressure. One trial is enrolling patients who are taking antihypertensive drugs, while subjects in the second study are off medications.
Medtronic is advancing toward pivotal data in parallel to ReCor, which is testing its Paradise renal denervation system in patients with stage 2 hypertension. In the coming years, the readouts from these trials could re-establish renal denervation as one of the hottest fields in medtech or cause it to sink to a new low.