The renal denervation race hit a major new milestone this week after Recor Medical’s Paradise system became the first to land FDA approval.
- Renal denervation (RDN) is intended for hypertension that can’t be controlled by conventional therapies, either due to ineffectiveness, side effects, or adherence issues
- RDN lowers blood pressure by denervating the sympathetic nerves surrounding renal arteries, reducing overactivity that can lead to hypertension
- Recor’s ultrasound-based Paradise System has been in development for 14 years, and gained European approval all the way back in 2012
Some might have seen this approval coming after an FDA expert panel endorsed the Paradise System in August, voting 10-to-2 that its benefits outweigh its risks.
- That was a far stronger result than Medtronic’s RDN system, which fell short with a 6-to-7 vote, but is still seen by some as on a path towards FDA approval.
The Paradise System’s FDA approval and panel endorsement were supported by Recor’s pivotal RADIANCE II trial, which found that the RDN system met both primary safety and effectiveness endpoints without any major adverse events.
- In fact, all three of Recor’s sham-controlled RADIANCE RCTs have met their safety and efficacy endpoints, including two off-medication trials that achieved a -4.5 mmHg average BP reduction.
Being first to market comes with obvious advantages, but online and conference chatter suggests that the Paradise System (and RDN in general) will face its share of post-approval challenges:
- Earning physicians’ trust in its impact and durability, and their confidence in identifying patients who are most likely to respond to RDN
- Overcoming physicians’ pharmaceutical-focused approach to hypertension
- Achieving reimbursements and a spot in clinical workflows
The staggering number of Americans living with uncontrolled hypertension and the clinicians who care for them now have a new tool to help bring their blood pressure under control. That could be huge for these millions of patients, and for Recor Medical, which is now the clear frontrunner in what might prove to be a multi-billion dollar market.