Some leading U.S. and European cardiologists favor curbs on sales or an outright moratorium on renal denervation devices.
After Medtronic's (MDT +0.7%) Simplicity clinical trial failed to meet its efficacy endpoint doctors question the continued use of the product to treat high blood pressure in patients who fail to gain enough of a benefit from drugs.
The therapy is currently approved in more than 80 countries. Analysts believe the U.S. market would be $3B if and when the FDA approves a device for the indication.
The renal denervation procedure uses a catheter to insert the device through the groin and into the kidney where it applies RF pulses to the renal arteries to damage the nerve endings in the vascular wall. Physicians believe these nerves contribute to elevated blood pressure.