A rendering of Medtronic’s Symplicity Spyral system, which uses radiofrequency energy to ablate the nerves near the renal artery.
The European Society of Cardiology and the European Association of Percutaneous Cardiovascular Interventions issued a consensus statement in March 2023 stating that renal sympathetic denervation can be used as adjunctive therapy for patients with uncontrolled hypertension who have had inadequate responses to medications and lifestyle changes. For individuals who cannot tolerate long-term medication or prefer not to take multiple medications (usually requiring the combination of two or more antihypertensive drugs), renal denervation can also be an option.
Minimally invasive surgery involves surgeons guiding catheters to the renal arteries. From there, they can use ultrasound or radiofrequency energy pulses to damage some of the sympathetic nerves in the arteries. The aim is to lower the patient’s blood pressure by reducing the overactivity of these nerves.
Lara Barghout, CEO of Recor, said in an interview, “Calming the nerves down helps reduce overactivity of the sympathetic nervous system and helps reduce hypertension.”
Currently, the standard of care for treating hypertension is medication and lifestyle changes. Treatment plans may involve layered use of multiple medications, including diuretics, β-blockers, and ACE inhibitors. “But these medications sometimes pose problems for patients, and compliance is even worse when too many medications are needed,” Barghout said.
Market Estimates
This statement could open up a market worth billions of dollars globally, as manufacturers of renal denervation devices have begun negotiations with insurance companies regarding reimbursement for treatment costs.
Jason Fontana, Vice President of Global Coronary and Renal Denervation Marketing and Strategy at Medtronic, said, “We must react to this information and communicate with government agencies and distributors.”
In recent years, Medtronic and ReCor have restored the reputation of renal denervation technology for treating hypertension, with data showing that selective renal artery denervation can lower blood pressure. These companies are vying for the European market, and the FDA approved their devices last year.
The U.S. Department of Health and Human Services estimates that nearly 120 million Americans (about half of all adults) have hypertension, but only about a quarter have their condition under control.
Currently, Recor is Medtronic’s only competitor in the U.S. market, but this situation is expected to change.
“I think this space is very important, and there will be more competitive devices in the future. That’s our expectation,” Barghout said. “And I believe the patient population is large enough to allow several competitors to enter the market.”
Device Development from China
At the 2023 European Interventional Cardiology Conference (euroPCR 2023), researchers shared trial data on blood pressure-lowering devices being developed by Suzhou Xinmai and Shanghai Guiliweiye. Clinical trials of renal denervation systems being developed by the two Chinese companies reached their primary endpoints. The two studies further demonstrated the safety and effectiveness of renal denervation therapy.
One study focused on a device developed by Suzhou Xinmai, which raised $100 million in financing at the end of 2021. The clinical trial randomly selected 219 individuals who were taking two or more hypertension medications but still had uncontrolled blood pressure for renal denervation, using SyMapCath I catheters and placebo treatments, respectively.
Six months later, the average blood pressure in the treatment group decreased by 25 mmHg. However, with the blood pressure in the control group also dropping by 27 mmHg, the treatment failed to demonstrate superiority over the placebo. Renal denervation did show an advantage in medication use, with the treatment group experiencing a smaller increase in the need for more medications or higher doses compared to the control group.
Another clinical trial tested the Netrod system developed by Shanghai Gui Liweiye. The results showed that renal denervation was associated with a decrease in blood pressure compared to the placebo. The average office blood pressure in the treatment group decreased by 25 mmHg, while it decreased by 6 mmHg in the control group. Although renal denervation had similar effects in both trials, the Gui Liweiye study had a higher response to the placebo.
Shanghai Guiliweiye raised funds at the end of 2022 to advance its renal denervation system.
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