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Covidien announces plans to exit OneShot renal denervation program
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Covidien has announced that it will voluntarily exit its OneShot Renal Denervation program in response to the slower than anticipated development of the renal denervation market.
This news comes less than 2 weeks after Medtronic issued a press release stating that the SYMPLICITY HTN-3 trial assessing its Symplicity renal denervation catheter in patients with treatment-resistant hypertension did not meet its primary efficacy endpoint.
The over-the-wire, balloon-based OneShot Renal Denervation system received a CE mark in February 2012, but is not approved for sale in the United States.
According to a press release issued by Covidien, the decision was based on the company’s review of strategic programs and growth potential for various aspects of its product portfolio. As a result of this decision, Covidien will end its RAPID II randomized study and anticipates recording after-tax charges of around $20 to $25 million.
During the next several weeks, Covidien will be collaborating with physicians and the renal denervation community to ensure current OneShot patients are informed and enrolling clinical trials are appropriately transitioned, Covidien stated in the release.
Covidien plans to continue to explore opportunities in the renal denervation market in the future.