Covidien to Exit OneShot Renal Denervation Program

January 21, 2014—Covidien (Mansfield, MA) announced it will exit its OneShot renal denervation program. The OneShot system is an over-the-wire balloon-based irrigated catheter technology for the treatment of hypertension.

According to Covidien, this voluntary action is primarily in response to slower-than-expected development of the renal denervation market. This decision resulted from the company's regular review of strategic programs and growth potential for various aspects of its product portfolio.

The OneShot system received European CE Mark approval in February 2012 and was introduced in Europe in May 2012. It was launched in international markets in January 2013. The OneShot system is not approved for sale in the United States.

Covidien stated that, as a result of this decision, it will not proceed with its RAPID II randomized study. Over the next several weeks, the company will collaborate with physicians and the renal denervation community to ensure existing OneShot patients are informed, and that 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. Additionally, Covidien expects to record after-tax charges in the range of $20 to $25 million as a result of exiting the OneShot program.