St. Jude Medical CEO’s Take on Failure of Medtronic’s Hypertension Clinical Trial

Posted in Cardiovascular by Jamie Hartford on January 13, 2014

Daniels Starks responded to news of Medtronic's Symplicity Renal Denervation System clinical trial failure. 

Last week Medtronic stunned the medical technology world when it revealed that the largest study of its first-generation renal denervation device had failed to meet its primary end point.

Six months after being implanted with the Symplicity Renal Denervation System, patients did not experience a reduction in high blood pressure.

The news was a surprise to all, including the CEO of St. Jude Medical, a rival of Medtronic also based in its home state of Minnesota.

When asked about the trial failure at the annual JPMorgan Healthcare Conference in San Francisco on Monday, Daniel Starks said that it is “too soon for us to know what to make of it.”

But he was willing to speculate.

“We note that the trial was done with a first-generation technology,” Starks said. “It may be that, among other things, the technology was too early stage. Was the technology too hard to be used effectively in an expanded environment? Was there a placebo effect? The news raised more questions than it provided answers.”

Starks pointed out that previous clinical trials of Medtronic’s device with smaller numbers of patients had proved that the technology works and those results are “still valid.” Based on that data and Medtronic’s guidance, analysts had fully expected the product to be approved.

St. Jude Medical, like other medical technology companies, has its own renal denervation program—the EnligHTN Renal Denervation System. Previously, at least one investigator of a trial testing St. Jude’s product said the company’s second-generation renal denervation was superior to that of Medtronic’s, primarily because it has multiple electrodes performing neurostimulation rather than the single-electrode Symplicity renal denervation catheter.

Globally, the market opportunity in renal denervation is estimated to be in the billions of dollars.

Starks added that the experience with the Atrial Fibrillation technology, where it took many years for the technology to become widely used, indicates that, “we have a warm trail and should continue to work at it.”

“None of this [Medtronic’s failure] will dissuade us in pursing this opportunity,” he concluded.

—Arundhati Parmar, senior editor, MD+DI


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