SYMPLICITY Results Make Life Difficult For Renal Denervation Programs

Article preview from IN VIVO - January 24, 2014

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.

SYMPLICITY Results Make Life Difficult For Renal Denervation Programs

Article preview from IN VIVO - January 24, 2014

Medtronic Inc.’s bombshell news, the disappointing clinical results for its Symplicity renal denervation product, left a smoking crater on the medtech landscape during last week’s JP Morgan Healthcare Conference in San Francisco. Large-cap executives and venture capitalists who saw great promise in the new therapeutic approach spent time trying to gauge the size and scope of the damage on the medtech industry and their own particular portfolios.

The SYMPLICITY HTN-3 trial followed two successful trials that demonstrated efficacy for the approach of ablating nerves within the renal artery to lower blood pressure in hypertension patients who have been resistant to drug therapies. The third trial – designed by Medtronic – was the first to institute a control arm of patients who underwent a sham procedure. The pivotal study was designed as a prospective, randomized, masked-procedure, single-blind trial evaluating the safety and effectiveness of the catheter-based device in patients taking at least three antihypertensive medications.

The primary effectiveness endpoint being measured was the change in office-based systolic blood pressure from baseline to six months. The results, announced January 9, suggest that while safe, renal denervation had no meaningful effect on hypertension. 

Continued...

To read this article in its entirety, Purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to IN VIVO.

Plus:

To find out about more about more about our medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact  Kristy Kennedy at (480) 985-9512