|Medtronic's Symplicity renal denervation device|
If Medtronic's ($MDT) recent U.S. clinical trial failure for its Symplicity renal denervation device throws the door wide open for its competitors, St. Jude Medical ($STJ) will likely waste no time walking through.
As MassDevice reported, St. Jude CEO Daniel Starks told an audience at the J.P. Morgan Healthcare conference in San Francisco that the company plans to keep plowing ahead with the development of its own technology.
"The fact that we had and that there have been favorable early clinical results in numerous other experiences is still valid," MassDevice quoted Starks as saying. "There is open surgical data dating back several decades that was favorable to the impact of surgical renal denervation to treat hypertension.'
That said, he also expressed genuine surprise about Medtronic's trial setback.
"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 in the story.
Medtronic's Symplicity device, which has a CE mark and is a market leader, had done well in previous trials in patients with different forms of hypertension and was on track to win FDA approval in 2015--potentially the first renal denervation device to reach that point. The Minnesota device giant announced a few days ago that Symplicity proved safe in a 535-patient trial but failed to significantly lower blood pressure for drug-resistant hypertension. This was a trial that mattered, designed to help fuel FDA approval. In the short term, the company suspended enrollment in three other related trials and announced plans to gather an independent panel of experts to plot a future course.
St. Jude Medical won a CE mark for its next-gen EnligHTN IV renal denervation system over the summer, but halted its own U.S. trial in December. Minnesota-based St. Jude said it had struggled to recruit viable candidates for the 590-patient trial, and was concerned that Medtronic's Symplicity might siphon off viable patients needed for its own study. At the time, St. Jude said it would work to develop a new protocol to address trial enrollment challenges.
Symplicity's setbacks may make that job much easier for St. Jude. They also create new opportunities for other rivals focused on developing similar technology, such as Boston Scientific ($BSX) and Covidien ($COV).
- read the full MassDevice story