plc (NYSE: COV) today 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 United States.
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 to $25 million 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.
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien develops, manufactures and sells a diverse range of industry-leading medical device and supply products. With 2013 revenue of $10.2 billion, Covidien has more than 38,000 employees worldwide in more than 70 countries, and its products are sold in over 150 countries. Please visit
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Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to effectively introduce and market new products, keep pace with advances in technology and compete effectively, implementation of healthcare reform in the United States and globally, cost-containment efforts of customers, purchasing groups, third-party payors and governmental organizations, rising commodity costs, risk of cyber-attacks, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations and the Foreign Corrupt Practices Act, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, manufacturing or supply chain problems or disruptions, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, risks associated with doing business outside of the United States, foreign currency exchange rates, environmental liabilities and tax legislation and potential tax liabilities. These and other factors are identified and described in more detail in our Annual Report on Form 10-K for the fiscal year ended September 27, 2013, and in subsequent filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.