Researchers at Columbia University Irving Medical Center and the Université de Paris, France, tested an ultrasound denervation catheter in its potential to treat hypertension. The technology is called the Paradise ultrasound denervation device and it has been developed by ReCor Medical, a medtech company with offices in California and the UK. The concept is based on the phenomenon whereby overactive neural activity in the kidney can lead to increases in sodium and water retention, underlying hypertension. The device is a catheter that can be advanced through the vasculature until it reaches the kidneys and then activated to produce ultrasonic disruption of nerve activity. In a recent clinical trial, the device was shown to reduce daytime ambulatory blood pressure by an average of 8.5 points and was largely well tolerated.
Hypertension is a common occurrence as many people age, but it can also strike in middle age. Lifestyle changes can help many patients, but in some cases this is not enough. Leaving high blood pressure uncontrolled can lead to a variety of adverse events. This has prompted this latest technology, renal ultrasound, as an alternative therapy.
The red circle indicates the heat generated from the ultrasound energy in the tissue delivering energy within the artery. The blue circle indicates active cooling from circulating water within the artery to protect the artery from heat.
“Many patients in our clinical practice are just like the patients in our study, with uncontrolled blood pressure in the 150s despite some efforts,” said Ajay Kirtane, a researcher involved in the study. “Renal ultrasound could be offered to patients who are unable to get their blood pressure under control after trying lifestyle changes and drug therapy, before these [adverse] events occur.”
The kidneys can play a key role in hypertension, with neural activity in this area leading to increased water retention. To date, there are no available treatments that target these nerves directly. The ultrasound catheter aims to achieve this by blasting the nerves with ultrasound, disrupting and calming their activity and reducing water retention.
The clinical trial included over 500 middle aged patients with hypertension. This was a mixed group of patients, with differing levels of hypertension severity and different medications. “The result was almost identical across the different study groups, which definitely shows that the device can lower blood pressure in a broad range of patients,” said Kirtane. “Once the device is available, we envision recommending it to patients who have tried other therapies first. The hope is that by controlling blood pressure, we might be able to prevent kidney damage and other effects of uncontrolled blood pressure,”
See a video about the technology:
Study in journal JAMA Cardiology: Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials
Flashbacks: ReCor PARADISE Gen 2 Renal Denervation System Gets EU Green Light; ReCor PARADISE Percutaneous Renal Denervation System Receives CE Mark
