Testimony at the FDA Advisory Committee Meeting on the Recor Paradise Ultrasound Renal Denervation System

August 22, 2023

The National Center for Health Research is a nonprofit think tank that focuses on the safety and effectiveness of medical products.

We recently testified at the FDA Advisory Committee Meeting regarding the Recor Paradise Ultrasound Renal Denervation (uRDN) System to discuss the science of uRDN device in reducing blood pressure. The Paradise uRDN is a device that uses ultrasound technology to ablate the renal nerves that drive sympathetic output in an effort to reduce blood pressure.

The evidence regarding the anti-hypertensive efficacy of the Paradise uRDN device is insufficient to justify its use as an adjunct therapy for hypertension. The data have clearly shown that the 24-hour ambulatory mean SBP lowering effect is less than almost all other anti-hypertensive medications at 60-days and only results in a mean lowering effect of 2.4 mmHg at 12-months. The reduction of blood pressure at 12-months is negligible and the results are not clinically meaningful. In 2018 the FDA decided that a reduction in blood pressure at 5-7 mmHg or more with a durability of 12-months would be clinically meaningful for denervation therapies, and the Paradise uRDN did not meet this threshold. Further, it is thought that the magnitude of blood pressure reduction through renal denervation decreases overtime due to sympathetic nerve regrowth after ablation.

Another important issue we highlighted is that the Paradise uRDN device has not been shown to reduce cardiovascular events such as heart attack and strokes- it is critical to remember that blood pressure is a surrogate endpoint for these measures. That is, lowering blood pressure alone does not necessarily improve cardiovascular disease, and there is no evidence to suggest that this device will prevent cardiovascular events in the short- or long-term.

We also pointed out that the device has been studied in a very limited and select patient population with hypertension. We know that hypertension frequently occurs in patients with other sympathetic mediated pathologic states such as congestive heart failure, atrial fibrillation, and obstructive sleep apnea but this device was tested in 0.4% of patients with heart failure, 0% with atrial fibrillation, and 8.9% with obstructive sleep apnea. Further, the studies were done on predominately white (78%) males (67%) with an eGFR of >60 (96.4%) and no history of type 2 diabetes mellitus (94.1%). What happens when this device gets out into the real world and is placed in patients who do not fit this limited scope?

While we appreciate that hypertension is a major public health burden that results in morbidity and mortality, we also believe that it deserves a sound, evidence-based solution. One that is superior to other treatment modalities, effective beyond 60-days, and demonstrated to reduce cardiovascular events. We urged the committee to consider that the results did not truly justify the invasiveness and cost of the Paradise uRDN device.