Two Hypertension Treatment Devices Subject of Circulatory System Devices Panel Review

The FDA’s Circulatory System Devices Panel will review premarket applications for two investigational renal denervation devices this week, both designed to help control refractory hypertension by ablating some of the sympathetic nerves that wrap around the renal artery.

Recor Medical’s Paradise Ultrasound Renal Denervation System (to be reviewed Tuesday) and Medtronic’s Symplicity Spyral Renal Denervation System (to be reviewed Wednesday) are both minimally invasive systems.

Theoretically, renal denervation should relax blood vessel walls, increase sodium excretion and decrease water retention, thus lowering blood pressure.

The devices are meant to be used in conjunction with medical therapy and lifestyle intervention. However, according to the FDA briefing documents on both devices, the durability of the procedure has yet to be confirmed, and the devices “pose the potential risk of damage to the kidney, tissues surrounding the renal artery, or the renal artery itself.”

To read the full story, click here to subscribe.

Related Topics