SCAI Issues Position Statement on Renal Denervation Ahead of FDA Panel Meeting

August 21, 2023—The Society for Cardiovascular Angiography & Interventions (SCAI) announced the release of a position statement on renal denervation (RDN) to treat hypertension (HTN) that emphasizes patient selection, optimal techniques, competence, training, and organizational recommendations.

The statement was published by Rajesh V. Swaminathan, MD, et al in JSCAI, the Journal of the Society for Cardiovascular Angiography & Interventions. Herbert D. Aronow, MD, served as Chair of the writing committee with Dr. Swaminathan as Vice Chair.

“Device therapies targeting the renal sympathetic nervous system hold promise as adjuncts to abate or interventions to abolish hypertension, depending upon the underlying severity of blood pressure elevation,” commented Dr. Aronow, in the SCAI press release. “This statement emphasizes that with appropriate patient selection, evaluation, and strict implementation of operator training standards and facility requirements, RDN treatment can be provided in an optimal fashion to this patient population.”

According the SCAI, HTN is a leading cause of death and disability globally, and the prevalence of uncontrolled HTN is on the rise. The impact of cost, side effects, and polypharmacy on quality-of-life often limit access and adherence to pharmacotherapy. Additionally, more than one half of individuals with high blood pressure do not achieve recommended treatment goal despite advocacy for lifestyle interventions and the availability of medications to address HTN.

The position statement notes that RDN is a minimally invasive procedure targeting sympathetic nerves adjacent to the renal arteries that has shown promising results in reducing blood pressure. Therapies such as RDN hold tremendous potential for the treatment of HTN. Furthermore, RDN may have beneficial effects on other conditions associated with sympathetic imbalance, including sleep apnea, left ventricular hypertrophy, albuminuria, and atrial fibrillation, advised SCAI.

The statement advises, “Pending FDA approval, guidance on appropriate integration of RDN into clinical practice will be of paramount importance to ensure standardization of clinical protocols and optimization of procedural outcomes.”

As the agency announced in June, the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee will hold a meeting virtually on August 22-23, 2023, from 9:00 am to 6:00 pm (EDT) to discuss, make recommendations, and vote on RDN devices indicated to reduce blood pressure in patients with HTN.

The premarket approval application (PMA) for the Paradise ultrasound renal denervation system (uRDN, ReCor Medical, Inc.) will be the focus of the August 22 session and the PMA for the Symplicity Spyral RDN (Medtronic) will be discussed on August 23.

The Day 1 webcast links are:

• YouTube (primary): https://youtu.be/Guz-BWP6cQc
• Teams (captions): https://teams.microsoft.com/day1

The Day 2 webcast links are:

• YouTube (primary): https://youtu.be/Gb2UZPVCgms
• Teams (captions): https://teams.microsoft.com/day2

More information including agendas and materials are available on the FDA Advisory Committee meeting page here.