SCAI: FDA panel vote “encouraging” for advance of renal denervation


FDAThe Society for Cardiovascular Angiography & Interventions (SCAI) has welcomed the review of scientific data related to the premarket approval applications for two renal denervation systems, describing this as a “step forward to advancing access to additional therapies for people with uncontrolled hypertension”.

The US Food and Drug Administration (FDA) Circulatory Systems Devices Panel met this week to review scientific evidence on interventions aimed at reducing blood pressure in patients with hypertension, scrutinising data for two renal denervation systems—the Paradise system from Recor Medical and Medtronic’s Symplicity Spyral device—as tools to reduce blood pressure in adults with uncontrolled hypertension, who may be inadequately responsive to, or are intolerant to, anti-hypertensive medications.

While the FDA panel voted in favour that available data supporting the efficacy and safety of both of the 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 Paradise system. For the Medtronic Symplicity Spyral device, the committee voted unanimously in support of safety, seven in support and six against on effectiveness, and six voted yes, seven against (with tiebreaker by chair) and one abstained on the benefits outweigh risks.

Read more:
Experts vote favourably on safety and efficacy of Paradise renal denervation system
Medtronic’s Symplicity Spyral renal denervation system splits panel over risk and benefit
SCAI position statement “aims to pave the way for renal denervation in the management of hypertension”

In a statement issued on Thursday, SCAI said that it 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 renal denervation are imperative to enhancing shared decision-making that can lead to better treatment and outcomes for patients,” the statement reads. “The FDA, renal denervation industry and healthcare personnel community spent many hours working and collaborating closely on these trials and deliberations for the betterment of patients and the care they receive.”

Ahead of the votes this week, SCAI released a position statement on renal denervation for hypertension regarding patient selection, best practices for optimal techniques, competence, training and organisational recommendations.

In conclusion, SCAI agrees that 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. 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.

“It is 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,” George Dangas (Icahn School of Medicine at Mount Sinai, New York, USA), SCAI president, was quoted as saying in the statement. “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.”


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