01.22.14
Covidien is getting out of the renal denervation to treat hypertension market. It seems that such as move was only a matter of time. The decision comes after a high-profile failure of a trial of a renal denervation device by Medtronic Inc. Covidien officials said the decision was based on the “slower than expected development” of the renal denervation market.
Renal denervation involves snaking a catheter through the femoral artery up to the renal arteries, where it uses heat to deactivate the renal nerves and, in theory, lower blood pressure.
As a result, the company’s OneShot renal denervation program and related trial (called RAPID II), which is currently under way, will come to an end. Covidien expects to record after-tax charges of between $20 million and $25 million due to the change. The device was approved in Europe in 2012 but not in the United States. In a statement, the company said it plans to work with patients and physicians to help switch them to another kind of treatment.
This decision resulted from Covidien’s “regular review of strategic programs and growth potential for various aspects of its product portfolio,” officials noted. The company also added that it “believes that the long-term hypertension market remains attractive and will continue to explore opportunities in this area.”
Earlier this month, Minneapolis, Minn.-based Medtronic said its experimental Symplicity renal denervation system did not do significantly better than a placebo in a large clinical study of patients with hypertension (high blood pressure).
Covidien and Medtronic aren’t the only companies to turn their backs on renal denervation for hypertension. Natick, Mass.-based Boston Scientific is planning to delay a trial of its experimental Vessix renal denervation product, according to the Bloomberg news service. The trial was planned to start in July, but CEO Michael Mahoney said his company will “wait and see and learn more about the Medtronic trial results before we have broad discussion with the FDA about what the trial design should be.”
Covidien is based in Dublin, Ireland, though it operates primarily out of Mansfield, Mass.
Renal denervation involves snaking a catheter through the femoral artery up to the renal arteries, where it uses heat to deactivate the renal nerves and, in theory, lower blood pressure.
As a result, the company’s OneShot renal denervation program and related trial (called RAPID II), which is currently under way, will come to an end. Covidien expects to record after-tax charges of between $20 million and $25 million due to the change. The device was approved in Europe in 2012 but not in the United States. In a statement, the company said it plans to work with patients and physicians to help switch them to another kind of treatment.
This decision resulted from Covidien’s “regular review of strategic programs and growth potential for various aspects of its product portfolio,” officials noted. The company also added that it “believes that the long-term hypertension market remains attractive and will continue to explore opportunities in this area.”
Earlier this month, Minneapolis, Minn.-based Medtronic said its experimental Symplicity renal denervation system did not do significantly better than a placebo in a large clinical study of patients with hypertension (high blood pressure).
Covidien and Medtronic aren’t the only companies to turn their backs on renal denervation for hypertension. Natick, Mass.-based Boston Scientific is planning to delay a trial of its experimental Vessix renal denervation product, according to the Bloomberg news service. The trial was planned to start in July, but CEO Michael Mahoney said his company will “wait and see and learn more about the Medtronic trial results before we have broad discussion with the FDA about what the trial design should be.”
Covidien is based in Dublin, Ireland, though it operates primarily out of Mansfield, Mass.