Ireland-based medical device company Covidien has announced it will exit its OneShot renal denervation program.
This voluntary action is primarily in response to slower than expected development of the renal denervation market.
The OneShot system is an over-the-wire balloon-based irrigated catheter technology for the treatment of hypertension. The system received CE Mark in February 2012 and is not approved for sale in the US.
This decision resulted from Covidien’s regular review of strategic programs and growth potential for various aspects of its product portfolio.
As a result of this decision the company will not proceed with its RAPID II randomized study. Additionally, Covidien expects to record after-tax charges in the range of $20-$25m as a result of exiting the OneShot program.
Over the next several weeks, the company will collaborate with physicians and the renal denervation community to ensure existing OneShot patients are informed and the currently enrolling clinical trials are transitioned appropriately.
Covidien believes that the long-term hypertension market remains attractive and will continue to explore opportunities in this area.