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A Medtronic hypertension procedure that can provide last-resort treatment for a condition that affects nearly half of all U.S. adults received Medicare coverage Tuesday, presenting a possible new revenue stream for the Minnesota-run medtech company. Dr. Joshua Jennings, a TD Cowen analyst, said in a note he expects the “very reasonable” terms of the Medicare coverage to “support a major growth opportunity” for Medtronic, as about 50% of American patients with uncontrolled hypertension are Medicare recipients. Medtronic has been under pressure from shareholders to make the company’s stock price more competitive, and CEO Geoff Martha has cited this technology among several growth-fueling innovations. The procedure, called the Symplicity Spyral Renal Denervation System, delivers radiofrequency (heat-creating) energy that stuns overactive nerves near the kidney, which contribute to high blood pressure. Having high blood pressure increases the odds of heart disease and stroke, and only about 25% of people with hypertension have it under control, per a Centers for Disease Control and Prevention estimate. Researchers previously reported drug and lifestyle treatment options have not slowed down the growing prevalence of hypertension. Symplicity provides another option for patients who haven’t improved with medication, diet or exercise. Analysts originally expected the Centers for Medicare and Medicaid Services to grant coverage for Symplicity on Oct. 8, but the government shutdown likely delayed the timeline, Jennings and a colleague said in a separate note. But the Centers temporarily sent its furloughed employees back to work Monday to manage the open enrollment period for health insurance, the Associated Press reported. Broad insurance coverage of the procedure will likely follow the Medicare approval. Martha previously said the company will lead the field. California-based Recor Medical also competes and benefits from the Medicare decision. Jason Fontana, renal denervation general manager, said in an email Medtronic is the market leader in the category. For Medtronic, commanding just 1% of the market for this procedure could generate $1 billion in revenue, a company spokeswoman previously said. “We are actively building out this new market in the U.S., including training physicians, building referral pathways and establishing Symplicity clinics,” Fontana said. “Our commercial teams will be actively leveraging this milestone, collaborating closely with health care providers and health systems as we accelerate the adoption of this transformative growth opportunity for Medtronic.” Medtronic has been working on this hypertension treatment since at least 2011, when the company bought a startup called Ardian. That eventually 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 start to gain steam following the Medicare announcement. He added Symplicity is the only system in it’s category with proven, long-term data. EVA MARIE UZCATEGUI/The New York Times The government website now shows consumers how much their health insurance costs will increase next year, as Congress remains at an impasse over the plans’ subsidies.
