SYMPLICITY Results Make Life Difficult For Renal Denervation Programs
The big slice of the device industry, from large-cap firms to venture capitalists, with some stake in the renal denervation opportunity are trying to understand the new reality now that Medtronic’s pivotal Symplicity renal denervation device trial missed its endpoint.
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Despite industry-wide contraction last year after Medtronic's SYMPLICITY, some believe a hypertension device is just around the corner. With a market estimated in the billions or even tens of billions of dollars, both Medtronic and Boston Scientific are launching redesigned studies, and a determined handful of medtech start-ups continue to pursue a device-based solution for treating hypertension with invasive and noninvasive approaches, including renal sympathetic denervation through radiofrequency, ultrasound, or drugs; neuromodulation in the forearm; and cold therapy to specialized cells in the neck.
Despite industry-wide contraction last year after Medtronic's SYMPLICITY, many agree the trial was flawed, and some believe a hypertension device is just around the corner. A determined handful of medtech start-ups continue to pursue a device-based approach, most by reducing “fight-or-flight” outflow from the sympathetic nervous system.
Manufacturers are finding it harder to innovate in the vascular interventional devices as market and regulatory pressures take their toll. New coronary drug-eluting stents face a difficult challenge with the high bar now set by existing devices, and there have been several recent disappointments in renal denervation, drug-coated balloons, and renal artery stenting; still there are some promising areas, with bioresorbable stents offering perhaps the best prospect among vascular therapies for future blockbuster status.