Covidien ($COV) said it will abandon a renal denervation development program due to slower-than-expected market growth for the hypertension treatment. It's yet another industry setback for a medical device concept that only weeks ago was still generating enormous enthusiasm and expectations in the U.S.
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Covidien's OneShot device Courtesy Covidien |
The Dublin-based med tech outfit's decision to pull back from its OneShot renal denervation system followed Medtronic's ($MDT) announcement earlier in January that a U.S. trial for its Symplicity renal denervation device failed to significantly lower blood pressure in patients with drug-resistant hypertension. Days later, Boston Scientific ($BSX) temporarily delayed the start of its own U.S. renal denervation study until more details about Medtronic's trial failure become known. So far, only rival St. Jude Medical ($STJ) has pledged to move forward with its EnligHTN IV renal denervation program, though it paused its own U.S. study, citing problems recruiting enough patients due to competition from Medtronic's trial.
Covidien made no mention of Medtronic in its announcement, and spokesperson Peter Lucht told FierceMedicalDevices that he "wouldn't comment about a competitor's announcement or product." But, he asserted, other reasons are at play in Covidien's decision.
"The primary reason for the decision was our own review of progress and potential around strategic programs, including renal denervation," Lucht said. "In this case, our analysis showed slower-than-expected growth for the renal denervation market."
Still, Covidien's announcement also holds a note of optimism about renal denervation treatments. It notes the company "believes that the long-term hypertension market remains attractive" and will keep looking for other viable treatment options in the space.
Renal denervation treatments for hypertension are already approved and still used in Europe. It's not quite a domino effect just yet, but renal denervation has gone rather rapidly from a hot development option to one that could now reach the U.S. market much later than expected. Covidien's actions may not be connected to Medtronic's trial failure and the fallout that has caused, but they reflect another negative development for the short-term advance in the U.S. of renal denervation to treat hypertension.
Covidien's OneShot system relies on over-the-wire balloon-based irrigated catheter tech to treat hypertension, and has had its CE mark since February 2012. The company said in its announcement that it would halt its RAPID II randomized study involving OneShot and record after-tax charges of up to $25 million to cover the cost of exiting the program. Covidien added that it would work with physicians and "the renal denervation community" to make sure existing OneShot patients are notified and those enrolled in clinical testing are cared for.
- read the Covidien release