On August 22 and August 23, 2023, the U.S. Food & Drug Administration (FDA) Circulatory System Devices Panel (CSDP) convened panels of the Medical Device Committee to review scientific evidence on interventions aimed at reducing blood pressure in patients with hypertension (HTN).

The panel discussed, made recommendations and voted on information regarding the premarket approval applications (PMA) for two renal denervation (RDN) systems as tools to reduce blood pressure in adults with uncontrolled HTN, who may be inadequately responsive to, or are intolerant to, anti-hypertensive medications.

While the FDA CSDP voted in favor that available data supporting the efficacy and safety of both of the RDN devices, votes differed on whether the benefits outweighed the risks. The Committee voted unanimously in support of safety, eight to three in support of its effectiveness, with one member abstaining, and 10 voted the benefits outweigh risks while two disagreed for the ReCor Paradise Ultrasound Renal Denervation System by ReCor, Inc. For the second RDN device under review, the Medtronic Symplicity Spyral Renal Denervation System by Medtronic, Inc., the Committee voted unanimously in support of safety, seven in support and six against on effectiveness, and six voted yes, seven against (tiebreaker by chair) and one abstained on the benefits outweigh risks.

The Society for Cardiovascular Angiography & Interventions (SCAI) is encouraged by the panel's vote as a step toward advancing access to additional therapies for people with uncontrolled high blood pressure. Advancements like RDN are imperative to enhancing shared decision-making that can lead to better treatment and outcomes for patients. The FDA, RDN industry and HCP community spent many hours working and collaborating closely on these trials and deliberations for the betterment of patients and the care they receive.

The panel comes at a time when an estimated 1.3 billion people suffer from HTN worldwide, but only around 40% are being actively treated. Of those, only 20% feel like their symptoms are under control. Despite the availability of medications and advocacy for lifestyle interventions to address HTN, more than half of individuals with high blood pressure do not achieve recommended treatment goals.

In addition, this week, SCAI released a position statement on RDN for HTN regarding patient selection, best practices for optimal techniques, competence, training and organizational recommendations. In conclusion, SCAI agrees that device therapies targeting the renal sympathetic nervous system hold promise as adjuncts to abate or interventions to abolish HTN, depending upon the underlying severity of blood pressure elevation. Appropriate patient selection, pre-procedure evaluation, careful procedural planning and technique, implementation of strict operator training standards and facility requirements are paramount to programmatic success.

This follows the 2021 proceedings from the cosponsored SCAI and National Kidney Foundation (NKF) expert consensus roundtable on RDN in HTN patients, historically resulting in a widespread consensus on the effectiveness and safety of RDN. Participants concluded that, should the interventional therapy gain approval in the United States, it has the potential for substantial public health impact to address an epidemic of uncontrolled HTN. 

Remarks from SCAI Leadership:

“It’s important we continue to seek out new treatment options for patients, including the use of renal denervation, given the growing global prevalence of uncontrolled hypertension increase year over year,” said George D. Dangas, MD, PhD, MSCAI, SCAI President, Professor of Medicine at the Mount Sinai School of Medicine and Director or Cardiovascular Innovation at the Zen and Michael A. Weiner Cardiovascular Institute of the Mount Sinai Medical Center, NYC. “The panels' vote will allow physicians and patients access to a renal denervation procedure for the first time with the potential to improve the treatment and quality of life for those suffering from hypertension.” 
 
“This week’s FDA panels on renal denervation underscore the importance of continued advancements and post-market research in this space,” said Binita Shah, MD, FSCAI, SCAI Trustee, and Associate Director of Research for the Cardiac Catheterization Laboratory at NYU Langone Health. “Renal denervation device therapies can potentially broaden access to additional ways physicians can treat patients with uncontrolled hypertension who may not respond to medications and lifestyle changes alone.”