On 10 December 2020, ReCor Medical , Inc, a wholly-owned subsidiary of Otsuka Medical Devices , announced it had received Breakthrough Device Designation from the FDA for its Paradise Ultrasound Renal Denervation System. This news came on the day that positive results for the system’s clinical trial were announced.
It is estimated that more than one billion people worldwide suffer from hypertension, which is a major cause of premature death. The primary treatments for hypertension include lifestyle changes and medication. When hypertension fails to respond to these treatments, it is referred to as “resistant hypertension” and becomes more difficult to treat.
Renal denervation is a novel catheter-based treatment that has been developed to treat resistant hypertension. It has been noted that resistant hypertension can be associated with chronic activation of the sympathetic nervous system. During a renal denervation procedure, a catheter is used to ablate the sympathetic renal nerves, using either radiofrequency or ultrasound ablation. This reduces the activity in these nerves, with the goal of lowering blood pressure in a long-lasting fashion.
A number of companies are in various stages of manufacturing devices for renal denervation and testing them in clinical trials. However, many of these trials were put on hold at the beginning of the Covid-19 pandemic in March 2020. At the end of that month, Medtronic announced positive clinical trial results for its Symplicity Spyral Renal Denervation System, which also received FDA Breakthrough Device Designation at that time. Medtronic’s catheter uses radiofrequency energy to ablate the renal nerve.
Now, a sense of competition has come to the renal denervation market with the FDA’s nod to ReCor Medical and their Paradise Ultrasound Renal Denervation System. As the device’s name indicates, the Paradise system uses ultrasound energy to ablate the renal nerve. On December 10, 2020, the company also announced that their device produced positive results in the RADIANCE-HTN TRIO (“TRIO”) study, details of which will be announced in 2021.
With two unique devices now having received FDA Breakthrough Device Designation, GlobalData predicts that the renal denervation market will begin to gain traction more quickly in the US. As more and more positive clinical trial data are released, physicians are more likely to be open to using renal denervation as a treatment once the devices receive proper FDA regulatory approval, which will likely happen in 2021.