Medicare to cover Medtronic’s hypertension treatment

Medtronic has been working on this hypertension treatment since at least 2011, when the company bought a startup called Ardian. That led to a clinical trial of a version of the Symplicity system in 2014.

The trial failed, with the procedure proved safe but not effective after six months because of multiple factors, such as medication changes.

“Everyone quit on hypertension,” Martha said in a recent interview. “In 2014, when the clinical trial data didn’t come back the right way, we stuck with it, and we’re going to pioneer this field. And then, others will follow.”

The company pushed on while competitors abandoned renal denervation. In 2022, a study of Symplicity’s long-term results showed procedure recipients displayed a statistically significant reduction in blood pressure compared to a control group. In November 2023, the technology received U.S. Food and Drug Administration approval.

The Symplicity procedure takes about an hour and uses a catheter — a thin, tube-shaped device — to access the renal arteries near the kidneys without open surgery. By destroying the tissue, doctors interrupt the signals of nerves in these arteries. That reduces blood pressure, as it dulls the effects of the body’s fight-or-flight response.

Fontana said procedure cases at hospitals will gain steam following the Medicare announcement. He added Symplicity is the only system in its category with proven, long-term data.