Medtronic reached a critical juncture last month in its quest to build the market for renal denervation, a new device-based treatment for uncontrolled hypertension, when the Centers for Medicare and Medicaid Services handed down a national coverage determination for its Symplicity Spyral system and Recor Medical’s Paradise device.
Nationwide Medicare coverage is expected to accelerate adoption of the procedure, which delivers energy to ablate nerves near the kidneys to lower blood pressure. The Food and Drug Administration approved renal denervation in 2023 for people whose blood pressure remains too high despite medication and lifestyle changes.
With more than 1 billion adults worldwide estimated to have hypertension, Medtronic executives expect the procedure to address an unmet need, and see it becoming an important growth driver for the company.
Jason Fontana, general manager of Medtronic’s renal denervation business, spoke with MedTech Dive about how the company plans to grow the market.
This interview has been edited for length and clarity.
MEDTECH DIVE: Medtronic worked for a long time to develop renal denervation as an option for hypertension patients. With the CMS national coverage decision now in place, how large of a market can it become?
JASON FONTANA: The hypertension opportunity is a big one. The persistence of uncontrolled hypertension within the Medicare population is very large. When you think of hypertension overall in the United States, the Medicare population is about 50% of those patients with hypertension. So it’s a big chunk of patients that, unfortunately, are suffering.
How has your organization been preparing for the NCD’s impact?
In terms of ramp-up and what we’re doing, when we saw the draft [NCD], we felt really positive, because it’s the work we already had underway. We had been working with hospitals to create hypertension programs, and some of those are more formal than others, but we’ve put in place the pathways and criteria to have patients get treated. We have folks in place. We call them market development experts. They’re experts in building programs and bringing physicians and hospital staff and nurses and healthcare professionals together to create a program.
We really have been focused on that. When we look at the NCD, it provides kind of the recipe now for these patients, and so we’re able to take what we’ve been doing and apply the final NCD, and we now have that guide for patients and for Medicare beneficiaries to get treated appropriately. It’s a big opportunity for us and something that we know how to do, because we’ve built markets before.
The CMS made some changes in how they defined hypertension and other criteria for coverage in the final NCD. What is the significance of those modifications?
In general, whether you’re an analyst or a patient or a doctor or hospital administrator, you’re trying to figure out what all this means.
We were trying to figure out if it was going to be “and” or “or” — either 140 over 90 or 140 and 90. Either way, that’s a really big patient population. That does not change our thought process from a macro level with the patients. It’s basically having that top number over 140 and the bottom number over 90.
One of the things we were really worried about was that they would have blood pressure and then a medication requirement. So they would say, somebody’s got hypertension and they’re on a certain number of medications. That didn’t happen.
Even in the CMS response to physician comments, from the draft to the final, they said patients do their best to take medications and have lifestyle modifications, but it’s really hard and there are adverse side effects. Basically, they said good faith effort to try medications and have lifestyle modifications, which is great. It brings the patient voice into the conversation. Do I want to continue to take medications I don’t feel great on, or do I want to try a procedure?
Where it was 12 weeks [on medical therapy], now it’s been cut in half to six, which is really more practical in that pathway for patients. The other one that is really important post-COVID, we’ve evolved to a virtual conversation with our physicians. So I could have two virtual conversations with the physician, or the primary or the physician assistant, and then one live confirmation meeting around that. They’ve made it more practical, more flexible.
Do you have a sense yet of which patients will benefit most from renal denervation?
We’ve actually done work with the FDA to put together what we call the patient preference study. This is asking patients, would you choose a procedure to treat your blood pressure versus taking another pill? Whether it’s in the U.S. or around the world, about a third of people who have uncontrolled hypertension would rather get a procedure than take another pill.
Probably, like most new-to-world therapies, [physicians will] treat the sickest of their patients first. And what I mean by that is, if they have the list of patients in their head, and this person’s trying to do their best — they’re on multiple medications and their blood pressure is really high — they’re treating that patient first because in their mind, that’s the patient really at risk.
What’s been so fulfilling is seeing the response in these patients. They speak about this fog that they have going away and just getting their life back. It’s really exciting to see the benefit they’re getting already from that blood pressure drop.
How quickly can you ramp up manufacturing to meet demand?
It’s a plan and an execution we’ve had in place for a while here. We also make coronary stents — we treat about 5 million patients a year with our coronary products — so we’re very used to creating products at high volume. We have a plant in Ireland, within Galway, that Medtronic uses, and we’ve been using for 30 years to produce a lot of these products. So we have those lines, and that operational facility has been up and running. We’ve been preparing for this day to be ready. We’re in really good shape for manufacturing.
