The recent decision by the Centers for Medicare and Medicaid Services (CMS) to cover renal denervation for uncontrolled hypertension could help expand access to and uptake of the treatment, according to doctors who perform the procedure.

The CMS decision on October 28 covers two renal denervation devices, Recor’s Paradise ultrasound system and Medtronic’s Symplicity Spyral radiofrequency system, which were approved by the FDA in 2023. A third device, the TIVUS ultrasound system from Boston Scientific, is in clinical trials and not included in the CMS decision.

The decision was made under the Coverage with Evidence Development process, meaning procedures will only be covered if they are performed as part of a CMS-approved study.

Renal denervation is a minimally invasive catheter-based therapy for patients with uncontrolled hypertension whose blood pressure is not adequately managed with lifestyle changes and medication. It targets the nerves around the kidney with ultrasound or radiofrequency energy to calm the overactive sympathetic nerves that play an important role in hypertension.

Excitement and Caution

Jiandong Zhang, MD, a cardiologist at Wake Forest University School of Medicine in Winston-Salem, North Carolina, said he hopes the CMS approval will increase uptake of the procedure for those who need it.

“As an interventional cardiologist I’ve performed this procedure and been involved with the clinical trials, and I’m very excited about the approval. But I also want to be cautious about it,” Zhang said. “This is not a procedure for everybody with high blood pressure. We need to be very careful with patient selection.”

Patients need to understand that the procedure is not a cure and that they will still need to continue taking their medications, he said.

Despite evidence of safety and efficacy, uptake of the technique since 2023 has been limited, Zhang said, partly because it was not covered by CMS. And private insurers tend to follow the agency’s lead on which procedures should be eligible for reimbursement, he noted.

Improvements Led to Approval

Naomi Fisher, MD, an endocrinologist and hypertension specialist at Mass General Brigham in Boston, said the underwhelming uptake of the procedure is also a hangover from the disappointing results of one early clinical trial. After two very promising studies, the Symplicity HTN-3 trial showed no significant difference in blood pressure reduction between the treatment and sham groups, and almost killed the entire field. “There were about 50 companies in this space, and all but twofolded,” Fisher said.

Improvements to the devices and the study methodology in second-generation trials led to better results and approval of two devices. But that one null result has had a lasting impact. “Many providers still think the field is dead because there was so much negativity around it,” Fisher said.

The CMS decision should help to alleviate some of those concerns, she added.

Fisher said there is an additional benefit of the CMS deciding to cover renal denervation, which is that it is shining a spotlight on the control of hypertension. “Hypertension is the leading modifiable risk factor for death around the world, but awareness and control have taken a back seat for decades,” she said. “So as a result of all the attention being paid to having a new device to treat it, we’re giving attention to controlling high blood pressure, which makes me really optimistic.”

Both companies welcomed the CMS decision.

“This is a transformative milestone for patients across the US who continue to battle uncontrolled hypertension,” Lara Barghout, CEO of Recor Medical, said in a news release. “CMS is paving the way for broader, more equitable access to this breakthrough therapy.”

“This milestone enables physicians to offer patients more choices when managing hypertension, potentially leading to better outcomes for a population in urgent need of new options,” Jason Weidman, president of Medtronic’s Coronary & Renal Denervation business, said in a news release.

Fisher reported consulting income from Medtronic, Recor, and Boston Scientific, as well as a research grant from Recor. Zhang reported no relevant financial conflicts. 

Brian Owens is a freelance journalist in New Brunswick, Canada.