A third of treated patients still cannot get their blood pressure under control.
High blood pressure has long been medicine's quiet adversary — present in over a billion lives, yet often invisible until the damage is done. On World Hypertension Day, Recor Medical draws attention to the stubborn third of patients for whom pills and lifestyle changes are not enough, offering a device-based therapy that quiets the overactive nerves driving their condition. The Paradise ultrasound renal denervation system, FDA-approved since late 2023, represents not a replacement for existing care but an expansion of what medicine can offer those left behind by it. Whether it will endure as a standard of care depends on the real-world evidence still being gathered.
- More than 1.3 billion adults live with hypertension globally — a figure that has doubled since 1990 — and roughly 400 million of them cannot control it despite medication and lifestyle changes.
- Uncontrolled blood pressure silently damages the heart, kidneys, and arteries, making resistant hypertension one of medicine's most consequential unsolved problems.
- Recor Medical's Paradise system targets the root of the problem differently: a catheter delivers short bursts of 360-degree ultrasound energy into the renal arteries, calming the overactive sympathetic nerves that push blood pressure upward.
- The device is FDA-approved, available in Europe and Japan, and backed by three randomized sham-controlled trials — but real-world registries in the US, Europe, and UK are still determining how well its promise holds in everyday practice.
- Risks including vascular complications and procedural pain mean the therapy is reserved for patients who have already exhausted conventional options, positioning it as a last-resort expansion rather than a first-line shift.
High blood pressure earns its reputation as the silent killer because it announces nothing. Millions live for years with dangerously elevated arterial pressure, feeling well, while their hearts and kidneys quietly sustain damage. By the time symptoms surface, the harm is often irreversible. This is the backdrop against which the medical world marks Hypertension Day each May 17th — and against which Recor Medical is making its case for a different kind of treatment.
The scale of the problem is difficult to overstate. More than 1.3 billion adults worldwide now have hypertension, double the number recorded in 1990. The World Health Organization considers it one of the most modifiable risk factors in medicine, yet it remains profoundly undertreated. For roughly one in three patients, the standard approach — medications, dietary changes, exercise — simply fails to bring blood pressure under control.
Recor Medical, a subsidiary of Otsuka Medical Devices, has developed the Paradise ultrasound renal denervation system to address this gap. The device targets a specific physiological driver of resistant hypertension: overactive sympathetic nerves surrounding the renal arteries, which push blood pressure upward when they fire too frequently. During the procedure, a catheter is guided into those arteries and delivers two to three seven-second bursts of 360-degree ultrasound energy, while a built-in cooling system protects the artery wall. The FDA approved the system in November 2023; it is also cleared in Europe and Japan.
Company leaders describe the technology not as a replacement for medication but as an additional tool for patients who have run out of conventional options. Three randomized, sham-controlled clinical trials support its use, and Recor is now generating real-world evidence through registries in Europe, the UK, and a post-approval study in the United States. The procedure carries risks — vascular complications, procedural pain, and vasospasm among them — and is indicated only for those whose blood pressure remains uncontrolled despite existing therapies.
For the hundreds of millions of people whose hypertension resists standard treatment, the arrival of a device that targets the underlying nerve activity represents a genuine expansion of options. Whether it becomes a durable part of hypertension care will depend on what the real-world data, still accumulating, ultimately reveals.
High blood pressure is often called the silent killer because it does nothing to announce itself. A person can live for years with dangerously elevated pressure in their arteries, feeling fine, unaware that their heart and kidneys are slowly being damaged. By the time symptoms arrive, the harm is often already done. This is why, as the world marks Hypertension Day on May 17th, the medical community continues to grapple with a stubborn problem: roughly one in three people being treated for hypertension still cannot get their blood pressure under control, even when they take multiple medications and change their lifestyle.
The numbers are staggering. More than 1.3 billion adults worldwide now live with high blood pressure—a figure that has doubled since 1990, when 650 million people had the condition. The World Health Organization tracks these trends carefully because hypertension is one of the most modifiable risk factors in medicine, yet it remains profoundly undertreated. When left uncontrolled, it leads directly to heart attacks, strokes, and kidney disease. For many patients, the standard toolkit—pills, diet, exercise—simply does not work.
Recor Medical, a subsidiary of Otsuka Medical Devices, is betting that a new approach can help close this gap. The company has developed the Paradise ultrasound renal denervation system, a minimally invasive device designed to address the root cause of many cases of resistant hypertension: overactive sympathetic nerves surrounding the renal arteries. These nerves, when overactive, drive blood pressure upward. The Paradise system uses ultrasound energy to calm them down.
The procedure itself is relatively straightforward. A catheter is threaded into the renal arteries, and the device delivers two to three doses of 360-degree ultrasound energy, each lasting seven seconds. The catheter includes a cooling system that circulates sterile water around the balloon to protect the artery wall during treatment. The FDA approved the Paradise system in November 2023, making it available to appropriate patients in the United States. It is also approved in Europe and Japan.
Helen Reeve-Stoffer, the company's chief operating officer, framed the innovation as part of a broader shift in how medicine approaches resistant hypertension. "World Hypertension Day is a powerful reminder that we must do more to close the gap between diagnosis and control," she said. The company is working to expand access to the technology, viewing it as a tool that works alongside—not instead of—medications and lifestyle changes. Dr. Shon Chakrabarti, Recor's chief medical officer, described the moment as the beginning of a new era in hypertension care, one where device-based therapies can offer patients a meaningful additional option when conventional treatments fail.
The clinical evidence supporting the Paradise system comes from three independent, randomized, sham-controlled studies in patients with mild-to-moderate and resistant hypertension. Beyond these trials, Recor is gathering real-world data through the Global Paradise System Registry in Europe and the UK, and through a post-approval study in the United States. This ongoing evidence generation matters because it will show whether the promise of the device translates into sustained benefit for patients in everyday practice.
Like any procedure, the Paradise system carries risks. Pain at the procedure site, vascular access complications, and vasospasm are the most commonly reported adverse events. Individual results vary, and the device is indicated only for patients whose blood pressure remains inadequately controlled despite lifestyle modifications and antihypertensive medications. For the roughly 400 million people worldwide whose hypertension resists standard treatment, however, the availability of a new option—one that targets the underlying nerve activity driving their condition—represents a meaningful expansion of what medicine can offer. Whether this technology will become a standard part of hypertension management, and for whom, will depend on how the real-world evidence unfolds.
Citações Notáveis
We are entering a new era in hypertension care—one where device-based therapies like the Paradise procedure can reduce blood pressure alongside medications and lifestyle changes.— Dr. Shon Chakrabarti, Chief Medical Officer of Recor Medical
We must do more to close the gap between diagnosis and control, helping physicians better manage patients whose blood pressure remains uncontrolled despite lifestyle changes and medication.— Helen Reeve-Stoffer, Chief Operating Officer of Recor Medical
A Conversa do Hearth Outra perspectiva sobre a história
Why does this matter now? Hypertension has been around forever. What's changed?
The scale has changed. We've gone from 650 million people with high blood pressure to 1.3 billion in three decades. And crucially, we've hit a wall with medications. A third of treated patients still can't get control. That's not a failure of effort—it's a failure of the tool.
So this ultrasound approach—is it replacing medication?
No. It's working alongside it. The idea is that for some people, their hypertension is being driven by overactive nerves around the kidneys. You can't pill that away. But you can calm those nerves with ultrasound energy delivered through a catheter.
That sounds invasive.
It is, but minimally. A catheter goes into the artery—the same way cardiologists do many procedures. The cooling system protects the artery wall. The whole thing takes minutes. For someone who's been on three medications and still has a stroke risk, that's not a heavy ask.
How do we know it actually works?
Three randomized, sham-controlled trials showed positive results. But that's the controlled world. Now they're running real-world registries to see what happens when thousands of patients get the procedure in actual practice. That's where the real answer lives.
What's the catch?
Pain at the access site, vascular complications, vasospasm. Nothing catastrophic, but real. And it's not for everyone—only for people whose blood pressure truly resists medication and lifestyle change. You have to be the right patient.
So we're waiting to see if this becomes standard care?
Exactly. The evidence is promising, but medicine moves slowly. What matters now is whether the real-world data holds up and whether doctors and patients embrace it as an option.