Top in cardiology: Renal denervation systems get mixed reception from FDA advisors

An FDA advisory panel recently voted that the risks of a radiofrequency renal denervation system outweighed its benefits. The majority was slim, with the panel chair having to step in and break a tie vote.

If approved by the FDA, Medtronic’s Symplicity Spyral radiofrequency denervation system would have an indication for BP reduction in patients with uncontrolled hypertension resistant to medication, or those for whom BP-lowering therapies are poorly tolerated, according to briefing documents from the FDA and Medtronic.

It was the top story in cardiology last week.

Another top story centered on the same panel’s 10-2 vote in favor of the risk-benefit profile of an ultrasound renal denervation system for adults with uncontrolled hypertension called Paradise, developed by ReCor Medical.

Read these and more top stories in cardiology below:

FDA panel says risks of radiofrequency renal denervation device outweigh benefits

A slim majority of FDA advisory panelists rejected that the benefits of a radiofrequency renal denervation system outweigh the risks for use in adults with uncontrolled hypertension despite use of antihypertensive medications. Read more.

FDA panel recommends ultrasound renal denervation device for uncontrolled hypertension

An FDA advisory panel voted 10-2 that the benefits of an ultrasound renal denervation system outweigh the risk for use in adults with uncontrolled hypertension who are unresponsive or intolerant to antihypertensive medications. Read more.

Aspirin underused in secondary CVD prevention, especially in lower-income countries

Aspirin is underused for secondary CVD prevention worldwide, particularly in lower-income countries, researchers reported in JAMA. Jeffrey S. Berger, MD, weighed in with a perspective. Read more.

One in 10 patients in cardiac ICU uses recreational drugs; half fail to disclose it

Use of recreational drugs such as cannabis, opioids, cocaine and amphetamines was prevalent in 11% of patients admitted to French cardiac ICUs and tied to increased odds of in-hospital major adverse events, researchers reported. Read more.

Start early, make health equity the ‘centerpiece’ for cardiometabolic interventions

Cardiometabolic health promotion should start early, be creative and include interventions that “focus on health, not just disease” to optimize outcomes for underserved populations, according to a speaker at the Women’s Cardiometabolic Health and Wellness Masterclass, hosted by the Cardiometabolic Health Congress. Read more.