FDA Expands Artificial Heart Valve Use

The FDA has expanded the approval of Medtronic’s CoreValve System to include “valve-in-valve” replacement, a first-of-its-kind use that will allow the device to treat certain patients who previously underwent a tissue aortic valve replacement and are in need of a second procedure.

The CoreValve is an artificial heart valve made of heart tissue taken from a pig. The device was previously approved to treat patients whose own aortic valve has become severely narrowed as a result of calcium buildup around the heart valve, but are considered to be at high risk for surgical aortic valve replacement.

The FDA based its recent nod on data from a clinical trial in which the safety and efficacy of the CoreValve System for aortic “valve-in-valve” replacement was evaluated in 143 participants. The researchers found that the estimated rate of survival without major stroke was 95.8% at 30 days and 89.3% at 6 months, results comparable to the corresponding rates reported for trial participants who received the device to replace their own aortic valve.

“The CoreValve System offers a less invasive treatment option for a significant number of patients with failed tissue aortic valves whose medical teams determine that the risks associated with repeat open-heart surgery are high or extremely high,” said William Maisel, MD, deputy center director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, in a press release. “The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology.”

Adverse events observed in trial participants included bleeding and complications with the arteries, while the major risks associated with the use of the device include acute kidney injury, heart attack, bleeding, complications with the arteries used to insert the valve, the need for a permanent pacemaker, and death.

Only patients who need replacement of a failed tissue aortic valve and are at extreme or high risk of death or serious complications from traditional open-heart surgery should be treated with the CoreValve System’s aortic “valve-in-valve” indication. The device should not be used in patients who have an infection, have a mechanical aortic heart valve, cannot tolerate blood thinning medicine, or have sensitivity to titanium, nickel, or contrast media.