- Medtronic failed to prove that its renal denervation system reduced patients’ ambulatory systolic blood pressure, the primary endpoint in clinical trial results presented at the American Heart Association (AHA) Scientific Sessions 2022. However, patients did see a statistically significant reduction in office-based systolic blood pressure, the trial’s secondary endpoint.
- All patients in the SPYRAL HTN-ON MED trial were prescribed blood pressure medications and one group was treated with Medtronic’s Symplicity Spyral renal denervation system, which uses catheter-based electrodes to ablate nerves in the renal artery.
- Medtronic has submitted the results to the Food and Drug Administration for premarket approval. William Blair analysts wrote in a research note that Medtronic still expects FDA approval by 2023. Which patients will be eligible and how much the company will be reimbursed for the device still is undetermined.
The results suggest that questions remain concerning Medtronic’s efforts to commercialize its renal denervation system. Last year, an interim analysis found the device failed to outperform a sham treatment, meaning the company missed an opportunity for an early FDA submission.
Medtronic’s shares fell on the news.
The most recent results were “surprising,” BTIG Analyst Ryan Zimmerman wrote in a research note, adding that Medtronic explained why the trial failed to meet its primary endpoint and still has an “abundance of clinical data” around its renal denervation program.
“Despite multiple trials not showing statistical significance (HTN-3 and ON MED) we think that [renal denervation] has still proven to be safe and effective and serves as an alternative to medication management in a multi-billion dollar market opportunity,” he wrote. “That said, what is less clear is the pathway to commercialization and [what] subsequent reimbursement the FDA and payers may grant for [renal denervation] treatment.”
Some remaining questions include the label indication, reimbursement and physician response, wrote William Blair analysts Margaret Kaczor and Brandon Vazquez.
“We think that there will be a population of cardiologists who will be willing to use this technology in spite of the missed primary endpoint. Our experience in interventional cardiology reflects many examples of promising technologies with mixed or incomplete definitive evidence being used with the goal of helping patients,” they wrote in a research note. “We expect Medtronic to continue to try to generate positive clinical data in support of this product, so it is doing this the right way, but the evidence presented here in our opinion is insufficient for now to drive market conversion to this therapy.”
Medtronic said that increased use of medication in the control group and possible effects of the COVID-19 pandemic may have affected the results and may explain why the renal denervation group did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure (ABPM), where patients wear a blood pressure cuff at home which take periodic readings throughout the day.
“Surprisingly, 24-hour ABPM declined with [renal denervation] but did not differ from the sham group, and the primary endpoint was not met,” said Dr. David Kandzari, the study’s lead investigator and chief of the Piedmont Heart Institute in Atlanta. “More than 80% of patients in the ON MED expansion group experienced follow-up during the Covid-19 pandemic. Compared with patients enrolled before the pandemic, significant differences in baseline 24-hour ABPM were observed that may reflect changes in patient behavior and lifestyle during the pandemic.”
A total of 337 patients were randomized between renal denervation and a sham control procedure. All patients in the study had been prescribed as many as three anti-hypertensive medications.
The study did meet its primary safety endpoint, with a low incidence of adverse events six months after the procedure. Renal denervation also outperformed a sham procedure when considering the combined reduction in blood pressure and reduction in medication burden for patients.
Currently, no renal denervation device is approved in the U.S., limiting the treatment to investigational use. However, the procedure is available in several other countries. Medtronic and ReCor Medical both have competing devices that are approved for use in Europe.
Medtronic’s stock dropped 4.9% to $81.33 in Tuesday morning trading.