However, the SPYRAL HTN-ON MED clinical trial’s six-month results did show improvement over Medtronic’s previous RDN efforts, the device maker said in a news release.
RDN is designed to treat hypertension with a one-time outpatient procedure that delivers energy to the nerves in the wall of the artery leading to the kidney. Medtronic’s Symplicity Spyral catheter device delivers radiofrequency energy through four electrodes.
Medtronic said it submitted the final module of the Symplicity Spyral Premarket Approval package to the FDA for review and approval.
More about Medtronic’s renal denervation trial results
The company presented the results yesterday as late-breaking clinical science at the 2022 American Heart Association (AHA) conference in Chicago.
Patients treated with the Symplicity Spyral RDN system in the trial while prescribed antihypertensive medications did not show a statistically significant reduction in 24-hour ambulatory systolic blood pressure compared to the sham control group. Medtronic said that was “due to increased medications in the sham control group and the potential impacts of the Covid-19 pandemic on the clinical trial environment.”
While the Symplicity Spyral RDN system failed to meet that primary endpoint, Medtronic said the treatment demonstrated a statistically significant and clinically meaningful reduction in office-based systolic blood pressure, a secondary endpoint.
The system met its primary safety endpoint, with Medtronic reporting a low rate of procedure-related and clinical adverse events.
“The study also included Win Ratio, a pre-specified secondary endpoint that combines reduction in blood pressure with reduction in medication burden, which enables assessment of the overall beneficial effect of RDN,” Medtronic said in the news release. “The Win Ratio demonstrated significance in favor of RDN versus a sham procedure.”
Medtronic sticks by overall results
Dr. Laura Mauri, Medtronic’s chief scientific, medical and regulatory officer, highlighted the RDN procedure’s safety and overall results in a statement.
“Renal denervation lowers blood pressure and requires less medication for patients with hypertension,” she said. “It is also a safe procedure. In this study specifically, RDN met both the safety endpoint for this trial, as well as the overall safety endpoint across the SPYRAL HTN ON and OFF MED studies.”
Medtronic executives have said RDN could be a billion-dollar business, making it one of the biggest opportunities for the medtech developer.
Shares of MDT fell nearly 5% this morning, trading around $81.69 near mid-day. For comparison, MassDevice’s Medtech100 index was up about 1% on the day.