FDA approves high blood pressure device from ReCor Medical

The Food and Drug Administration approved a surgical system used to reduce blood pressure from ReCor Medical, the company announced Wednesday. The treatment, called renal denervation, is controversial in the cardiology community due to its unclear efficacy.

Renal denervation is a treatment for patients who cannot manage standard doses of blood pressure medication — whether because the drugs aren’t effective enough for them, create overwhelming side effects, or become too cumbersome. The therapy, which is meant to be a one-time procedure, is administered via a catheter. Electrodes on the catheter then emit radiofrequency or ultrasound energy to block nerve signals from the kidneys that increase blood pressure.

The therapy, a simple procedure to reduce the blood pressure of millions of Americans, was once seen as a boon for cardiologists and device makers. But a large-scale clinical trial from Medtronic in 2014 called renal denervation’s efficacy into question, as it did not significantly reduce blood pressure compared to placebo treatments.