SCAI Leadership Remarks on FDA Panel Meeting on RDN

August 24, 2023—The leadership of the Society for Cardiovascular Angiography & Interventions (SCAI) issued a statement regarding the FDA Circulatory System Devices Panel that convened on August 22 to 23 to review scientific evidence on two interventional renal denervation (RDN) devices aimed at reducing blood pressure in adult patients with uncontrolled hypertension (HTN) who may be inadequately responsive to, or intolerant to, antihypertensive medications.

The FDA panel discussed the evidence, made recommendations, and voted on information regarding the premarket approval applications for the two RDN systems: the Paradise ultrasound RDN system (ReCor Medical) and the Symplicity Spyral RDN system (Medtronic).

As the SCAI statement noted, the FDA panel voted in favor that available data support the efficacy and safety of both RDN devices; however, the votes differed for the devices on whether the benefits outweighed the risks.

For the Paradise system, the panel voted unanimously in support of safety (12-0); eight to three in support of its effectiveness, with one member abstaining; and 10 to two that the benefits outweigh the risks of treatment with the device.

For Symplicity Spyral, the panel voted unanimously in support of safety (13-0); on effectiveness, they voted seven for and six against; and on whether the benefits outweigh risks, they voted six to seven (tiebreaker by chair), with one panel member abstaining.

The SCAI leadership stated, “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 health care professional community spent many hours working and collaborating closely on these trials and deliberations for the betterment of patients and the care they receive.”

On August 21, in advance of the panel meetings, SCAI announced a position statement regarding patient selection, best practices for optimal techniques, competence, training, and organizational recommendations.

In conclusion, the leadership stated, “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, preprocedure evaluation, careful procedural planning and technique, implementation of strict operator training standards, and facility requirements are paramount to programmatic success.”

The current statement noted that in August 2021, SCAI announced the release of a proceedings document outlining the possible role of RDN as a therapeutic option to complement medical therapy and lifestyle interventions for patients with uncontrolled HTN. The SCAI Think Tank Proceeding was published by David E. Kandzari, MD, et al online in Catheterization & Cardiovascular Interventions.

The 2021 document 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. This document resulted in a widespread consensus on the effectiveness and safety of RDN, noted SCAI.

In the current SCAI announcement, SCAI President, George D. Dangas, MD, and SCAI Trustee, Binita Shah, MD, commented on the FDA panel outcomes.

“It’s important we continue to seek out new treatment options for patients, including the use of RDN, given the growing global prevalence of uncontrolled HTN increase year over year,” stated Dr. Dangas, Professor of Medicine at the Mount Sinai School of Medicine and Director of Cardiovascular Innovation at the Zen and Michael A. Weiner Cardiovascular Institute of the Mount Sinai Medical Center in New York, New York. “The panel’s vote will allow physicians and patients access to an RDN procedure for the first time with the potential to improve the treatment and quality of life for those suffering from HTN.”

Dr. Shah, Associate Director of Research for the Cardiac Catheterization Laboratory at NYU Langone Health in New York, New York, added, “This week’s FDA panels on RDN underscore the importance of continued advancements and postmarket research in this space. RDN device therapies can potentially broaden access to additional ways physicians can treat patients with uncontrolled HTN who may not respond to medications and lifestyle changes alone.”