The companies argued their premarket approval cases to an FDA expert panel last week, and only ReCor walked away with panel support.
- The panel endorsed the ReCor Paradise System’s hypertension efficacy with a 8-3 margin (one abstained) and a unanimous 12-0 vote supporting its safety, leading to a solid 10-to-2 vote that the Paradise’s benefits outweigh its risks.
- The panelists supported the Medtronic Symplicity Spyral’s efficacy with a narrower 7-6 margin, and another unanimous safety vote, but only 6 out of 7 found that the system’s benefits outweigh its risks.
Although the judges still had plenty of concerns about study design and potential use, ReCor’s ultrasound-based RDN device passed with the help of its three sham-controlled RCTs, including two off-medication trials with a -4.5 mmHg average BP reduction.
Medtronic likely expected the panel to be challenging, given that only one of its catheter-based RDN system’s two trials met its primary effectiveness endpoint (for off-medication patients). The panelists did see how the Symplicity Spyral could benefit patients, but concerns about trial results, study design, and a mismatch between the results and the device’s proposed indication led to their decision against its PMA.
Despite these very different results, both devices might still be on track for FDA approval, noting that the FDA often follows panel advice but isn’t obligated to, and some analysts still believe Medtronic could gain FDA approval.
- Both devices are also already approved in Europe, and have more ongoing trials to support future regulatory decisions.
Although the FDA’s actual decision is still pending, it’s hard not to view ReCor Medical as the new renal denervation frontrunner given its stronger study results and advisory panel acceptance.
More notable from a patient care perspective, it appears that the US is closer than ever to having a FDA-approved renal denervation system available. That addition to clinicians’ hypertension treatment toolbox could be notable, given that millions of people are living with high BP that can’t be controlled with current medications (or with patients’ challenges with medication adherence).