The FDA Circulatory System Devices Panel has voted in favor of the benefit-risk profile of Recor Medical's RDN system in a 10-2 vote but declined to endorse Medtronic's system in a 6-7 vote.
The US Food and Drug Administration (FDA) Circulatory System Devices Panel (CSDP) has voted on 2 renal denervation (RDN) systems as a tool to reduce blood pressure in adults with uncontrolled hypertension.1
On August 22 and August 23, respectively, the FDA CSNP convened panels of the Medical Device Committee to review the premarket approval applications for the ReCor Paradise Ultrasound RDN System by ReCor, Inc. and the Medtronic Symplicity Spyral RDN System by Medtronic, Inc.
The FDA CSDP committee's votes differed on the benefit-risk profile for each device, voting in favor of the RDN system from ReCor, Inc. and declining to endorse the RDN system from Medtronic.
“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, associate director of research, Cardiac Catheterization Laboratory at NYU Langone Health, in a statement from the Society for Cardiovascular Angiography and Interventions (SCAI).1 “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.”
ReCor Paradise Ultrasound
The votes for the ReCor Paradise Ultrasound system were favorable, suggesting sufficient data to support the device in patients with uncontrolled hypertension.2
Committee members voted 12-0 in favor of the Paradise Ultrasound system for safety and 8-3 in favor of efficacy, with a single vote abstaining. Regarding the benefit-risk profile, the committee voted 10-2 in favor of the Paradise system's benefits outweighing the risks.
“I was pleased to see that the advisor committee recognized the adjunctive benefits of the Paradise Ultrasound RDN system in lowering blood pressure – something that we sought to demonstrate definitely through the generation of high-level scientific evidence within the RADIANCE global program,” said Ajay Kirane, co-primary investigator of the RADIANCE global program and a professor of medicine at Columbia University.2
Medtronic Symplicity Spyral
Meanwhile, the committee was unanimous with a 13-0 vote on the safety of Medtronic’s Symplicity Spyral RDN System.3 However, the committee was split at 7-6 on the effectiveness of the Symplicity blood pressure procedure.
Ultimately, the vote was closely divided on the benefit-risk profile of the device, tied at 6-6. A single committee member abstained from the vote on whether the benefit profile outweighed the identified risks. Ultimately, the panel chair broke the tie and chose not to endorse the system, resulting in the final 6-7 vote.
“The Symplicity Blood Pressure Procedure has the potential to fill a significant unmet need in hypertension care, and we know patients are looking for options in addition to medication and lifestyle modifications to manage their blood pressure,” said David Kandrazi, MD, principal investigator of the SPYRAL HTN-ON MED clinical trial and chief of the Piedmont Heart Institute and Cardiovascular Services.3
Panel recommendations will be considered by the FDA as the agency continues to review both devices for market approval in the US.1
Earlier this week, the SCAI released a position statement on renal denervation for hypertension, confirming the promise as adjuncts to abate or interventions to abolish hypertension, depending upon the underlying severity of blood pressure elevation.
The SCAI indicated appropriate patient selection, careful procedural planning and technique, and implementation of strict standards will be paramount to the success of renal denervation.
“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, president of SCAI, in a statement.1 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.”