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Medtronic plans new study of blood pressure-lowering device
2015年2月17日 / 晚上7点53分 / 3 年前

Medtronic plans new study of blood pressure-lowering device

CHICAGO Feb 17 (Reuters) - Medical device maker Medtronic Plc said on Tuesday it planned to seek approval from U.S. regulators to begin a new study of its version of a hypertension treatment in which nerve connections between the heart and kidney are disrupted.

Called renal denervation, the treatment involves creating tiny scars along the nerves and is intended for patients whose high blood pressure cannot be controlled with drugs.

Medtronic had a jump start in developing the catheter-based renal denervation treatment for the U.S. market but discontinued an initial study last year when its device failed to demonstrate effectiveness.

On Tuesday, company officials said they were discussing a new design for a clinical trial with the U.S. Food and Drug Administration and plan to formally submit a request to begin the study with a next-generation device.

The plan was disclosed as Medtronic reported better than expected quarterly earnings, driven by growth in its cardiac and vascular business.

Medtronic Chief Executive Omar Ishrak said the company has analyzed what went wrong in the previous trial and remains confident in its leadership in the field.

“The fact is that uncontrolled hypertension is a serious problem. Patients need help. The concept of renal denervation is a sound concept,” Ishrak said in an interview.

The company has been working with numerous experts on the study design, which will be used to apply to the FDA for an investigational device exemption, said Michael Coyle, who heads Medtronic’s cardiac and vascular group.

“We still have work to do, but I think we know what we want to do with the next IDE study, and we will see if we can come to agreement with the agency on moving forward with it,” Coyle said on the company’s earnings conference call.

Medtronic competitors St Jude Medical Inc and Boston Scientific Corp also are developing renal denervation devices. (Reporting by Susan Kelly; Editing by Christian Plumb)

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