Replacement heart valve approved for more patients

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Irvine, California: The US Food and Drug Administration has approved the expanded use of the Intuity Elite rapid deployment replacement aortic valve made by Edwards Lifesciences, thus increasing the treatment options for patients with complex heart disease, the company announced. The valve is designed for use in transcatheter aortic valve replacement, a procedure in which the surgeon does not remove the damaged valve, but simply presses the new valve into place; the procedure is preferred to more invasive open-heart surgery, particularly for patients who have other heart problems or are at serious risk of stroke, as it reduces recovery time and lowers the risk of infection. Although the device received approval in the European Union in 2014, it has until now only been approved for very high-risk cases in the US. “This is the first time in the US that a transcatheter aortic valve has been approved for use in intermediate-risk patients,” cardiovascular devices director Dr. Bram Zuckerman of the FDA’s Center for Devices and Radiological Health said in a statement. “This new approval significantly expands the number of patients indicated for this less invasive procedure for aortic valve replacement.”

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