ARTICLE SUMMARY:
Recor Medical is expanding access to its ultrasound renal denervation technology with the help of Medicare coverage, professional guidelines, and clinical results supporting renal denervation for the treatment of drug-resistant hypertension. Excerpted from our recent feature “Renal Denervation Winds Shift in Recor’s Favor.”
Three years after it launched the Paradise ultrasound renal denervation (RDN) system in the US, Otsuka subsidiary Recor Medical is addressing the remaining barriers keeping patients with uncontrolled hypertension from accessing this potentially life-changing therapy.
“Right now, the barrier is financial,” explains Helen Reeve-Stoffer, PhD, who was recently promoted from Recor Medical’s chief operating officer to CEO after 13 years with the company. “When we became commercial back in 2023, there was really no investment at all, no reimbursement process. That has improved over the last three years.”
In December 2025, CMS issued a national coverage determination (NCD) extending Medicare “coverage with evidence development” (CED) to RDN procedures performed in CMS-approved studies. “That is helping the Medicare population by ensuring coverage and we're starting to see some leverage with some of the private payors so that they're creating their own coverage portfolio profiles,” Reeve-Stoffer explains.
And in September, the American Medical Association’s Current Procedural Terminology (CPT) Editorial Panel created two Category I CPT codes describing renal denervation that will become effective January 1, 2028. “That should, theoretically at some point, add on additional reimbursement,” she adds.
Clinical evidence development is an important part of Recor’s strategy to secure reimbursement for renal denervation with ultrasound. Two-year results from 243 patients in the pivotal RADIANCE program showed an average reduction of 15.7 mm Hg in office systolic blood pressure. Six-month results from 212 high-risk patients in the Global Paradise System Registry—a real-world “all-comers” international registry—showed a 19.6 mm Hg reduction in home systolic blood pressure and a 14.4 mm Hg reduction in home systolic blood pressure.
“The fact that we can show that blood pressure remains low for that amount of time indicates that the cardiovascular risk reduction is probably maintained and that has huge implications for the patient,” Reeve-Stoffer says. The consensus of previous research on blood-pressure reduction suggests that the magnitude of blood-pressure reduction created by renal denervation will reduce patients’ cardiovascular risk. (See “Medtronic Invests to Extend RDN’s Reach,” MedTech Strategist, June 23, 2026.)
“It also has huge implications for the system as well because, obviously, if you're reducing strokes, heart failure, and the progression of cardiovascular disease, theoretically you can reduce the costs of that burden on the healthcare system,” the CEO continues.
However, health insurers are reticent to pay for “theoretical” benefits, so companies developing RDN technologies are investing in studies that measure critical patient outcomes.
“The drop in blood pressure is a surrogate for cardiovascular risk reduction, but the payors have been much more conservative,” Reeve-Stoffer explains. The outcomes mandated by CMS’ CED policy include measurements of renal function, cerebrovascular accidents, heart attacks, heart failure, and mortality for at least two years, along with the standard blood-pressure measurements.
Currently, there is no reliable way to predict how much benefit a patient will receive from renal denervation except that, in general, patients who show the biggest drop in blood pressure after the procedure are usually those with the highest baseline blood pressure. “There is huge energy right now” among researchers to identify which patients are most likely to benefit from the therapy,” Reeve-Stoffer says.
Recor also sees opportunities to continue refining the ultrasound RDN technique to optimize the procedure. “Over the years of understanding where the nerves actually are, running along the side of the renal artery, [we are] able to ‘play around’ with the settings of the ultrasound [to] specifically target … where you want it to go,” Reeve-Stoffer points out.
The company is also investigating other indications for Paradise, including denervation of the nerves around the hepatic artery to further reduce blood pressure.
While working with payors to ensure RDN is covered, Recor is also trying to reach patients directly because many people with dangerously high blood pressure are unaware of their options and are not working with a cardiologist who could educate them about RDN.
Reeve-Stoffer recalls that Recor relied on direct-to-patient marketing to recruit patients into clinical trials starting around 2014, because so few of hypertensive patients were seeing a cardiologist. Now the company is using targeted marketing via social media “so patients can advocate for themselves.”
Recor is also reaching out to the patients who are already being treated for hypertension with multiple medications. “There is definitely a population that would prefer to have a procedure versus medication,” Reeve-Stoffer says. “Most people don't have that many side effects from the actual disease. What they have are side effects from the multiple drugs they're on.”