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Renal denervation updates: ReCor Medical’s Paradise and Medtronic’s Symplicity Spyral

August 31, 2023

What’s new in renal denervation?

Two renal denervation systems were recently considered by a Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee.

On August 22, 2023, the panel unanimously agreed that ReCor Medical’s Paradise Ultrasound Renal Denervation (RDN) System was safe and voted eight to three in favor, with one vote abstaining, for the efficacy of the system to treat hypertension. Ultimately, the majority believed the benefits of the system outweigh the risk, voting ten to two in favor. Some panelists voiced concern about the durability of the treatment’s effect beyond the first two months and expressed hope that the FDA will include those potential limitations in its labeling for the system. (Endovascular Today 2023).

The next day, that same panel found Medtronic’s Symplicity Spyral RDN system safe and overall efficacious (seven in favor, six against), but decided not to recommend the system after determining that the benefits of the platform did not outweigh its risks, with a final vote of 7 against, six in favor, and 1 abstaining. (Endovascular Today 2023).

The FDA will now decide whether to approve the systems.

What’s the potential patient impact?

Hypertension resulted in more than 690,000 deaths in the U.S. in 2021. Nearly half of adults have hypertension, and only 25% of those have the condition under control. (CDC 2023)

According to the American College of Cardiology, RDN may play an important role in the treatment of adults with uncontrolled or resistant hypertension, as well as those who are unable to tolerate long-term medications. RDN should be offered mainly to patients with high global cardiovascular risk, for whom intensive BP treatment may have a particularly pronounced benefit.

What’s the evidence?

ReCor Medical, a subsidiary of Otsuka Medical Devices, presented findings that involved randomized, sham-controlled clinical trials of the Paradise system. The trials included more than 500 patients with mild to moderate or resistant, uncontrolled hypertension. All three studies met their primary effectiveness endpoints by reducing the mean change in daytime systolic blood pressure at two months in the absence of antihypertensive medications. (Azizi 2023)

Late last year, Medtronic announced that the Symplicity Spyral system failed to outperform antihypertensive drugs, attributing the outcome to the pandemic and medication changes for patients enrolled in the study. (Hammerand 2023)

How do the platforms work?

The Paradise Ultrasound RDN System delivers ultrasound energy via a catheter to disrupt signals from overactive nerves along the renal arteries. The platform is intended for use in people with uncontrolled hypertension who cannot tolerate or who don't respond to medication. (Endovascular Today)

Medtronic’s Symplicity Spyral RDN is also a catheter-delivered system but uses radiofrequency energy instead of ultrasound. (Hammerand)

Sources:

Azizi M, RADIANCE II Investigators and Collaborators. (2023, Feb 28). JAMA. Endovascular ultrasound renal denervation to treat hypertension: The RADIANCE II randomized clinical trial. https://pubmed.ncbi.nlm.nih.gov/36853250/

(2023, Aug 23). Endovascular Today. FDA advisory panel split on Medtronic’s Symplicity Spyral renal denervation. https://evtoday.com/news/fda-advisory-panel-split-on-medtronics-symplicity-spyral-renal-denervation).

(2023, Aug 22). Endovascular Today. FDA panel’s vote supports ReCor’s Paradise Renal Denervation Platform for patients with uncontrolled hypertension. https://evtoday.com/news/fda-panels-vote-supports-recors-paradise-renal-denervation-platform-for-patients-with-uncontrolled-hypertension

(2023, Jul 6). Facts about hypertension. CDC. https://www.cdc.gov/bloodpressure/facts.htm

Hammerand, J. (2022, Nov 8). Medical Design & Outsourcing. What’s next for Medtronic RDN after Symplicity Spyral trial ‘surprise’? https://www.medicaldesignandoutsourcing.com/medtronic-rdn-fda-approval-reimbursement-commercialization/