|Medtronic's Symplicity Renal Denervation System|
The procedure was vaunted as possibly a way out of drug therapy for millions who take multiple medications but cannot lower their high blood pressure. Medtronic, one of the forerunners of this technology obtained via its $800-million acquisition of Ardian, dropped this bombshell in January: the largest clinical trial ever to test the safety and efficacy of the procedure had failed to meet its primary endpoint – to lower blood pressure six months following the procedure.
The result shocked analysts who had expected Medtronic to breeze through the approvals process and get the Symplicity Renal Denervation System on the market in 2015. Medtronic had previously described renal denervation as a “multi-billion dollar opportunity.”
Shortly after Medtronic's stunning announcement, Covidien said that it was pulling out of renal denervation in Europe because of slow market growth.
Other companies like St. Jude Medical and Boston Scientific are pursuing the therapy, although their products are not commercially available.
“One of the industry’s disappointments in 2014 was the renal denervation (RDN) segment,” says Bob Lavoie, managing director and partner, L.E.K. Consulting, who leads the company’s Medtech practice. “Looking back to 2013, the expectation for renal denervation was certainly quite bullish. However, in 2014, therapies in this sub-segment of the market have fallen well short of expectations, suffering some clinical setbacks.”