St. Jude Medical (NYSE:STJ) CEO Daniel Starks remains steadfast in his pursuit of renal denervation in treatment of hypertension, despite the high-profile clinical trial flop suffered just last week by rival medtech titan Medtronic (NYSE:MDT).
St. Jude will continue with its renal denervation initiatives and Starks still sees the technology as a potential winner, he told an audience today at the J.P. Morgan Healthcare conference in San Francisco.
"I think we’re just in the very early stages of figuring out how to best help patients with a renal denervation procedure, but there’s nothing in [Medtronic’s] announcement that dissuades us from continuing to pursue this," Starks said.
Medtronic’s highly anticipated SYMPLICITY HTN-3 clinical trial, the 1st of its kind to analyze renal denervation in a blinded, sham-controlled manner, failed to meet endpoints for efficacy in treating patients with drug-resistant hypertension. The announcement came as a shock to many, including Starks who said that he and his colleagues were still processing the news and waiting for more data.
"This was unexpected for us, to have a negative result from Medtronic’s trial, and it’s too soon for us to know what to make of that," Starks said. "It really raises far more questions than it provided answers."
Read MassDevice.com’s in-depth look at renal denervation and bias in hypertension clinical trials.
Medtronic has yet to release the bulk of the data from the trial, so it’s difficult to analyze the possible reasons that renal denervation failed to produce the types of results that many had anticipated based on previous, less-robust studies. Medtronic conducted the trial with its 1st-generation denervation technology, and it’s possible that newer systems may have done a better job, Starks mused.
"It may be that the trial was done with a technology that was too early-stage – that’s speculative on my part, but that’s among the list of questions that we have," he added. "Was the technology effective or was it that the technology was really too hard to use effectively in an expanded environment?"
There are many more questions that Starks would like answered before making a judgment on Medtronic’s trial, he said, but, meanwhile, the news has done little to dampen his enthusiasm for renal denervation and its promise in treating patients with hypertension.
Starks cited years of clinical studies supporting renal denervation, especially in treating patients whose hypertension isn’t well-controlled with drugs.
"The fact that we had and that there have been favorable early clinical results in numerous other experiences is still valid," Starks said. "There is open surgical data dating back several decades that was favorable to the impact of surgical renal denervation to treat hypertension."
St. Jude has suffered some renal denervation setbacks of its own, announcing in December that the company would halt the Enlightn IV clinical trial, just a few months after it began. The study was slated to assess nearly 600 patients, but it was halted over concerns that Medtronic’s Symplicity device would hit the market and hinder enrollment.
