Medtronic valve meets study goals

Updated: July 20, 2009 - 10:40 PM

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WASHINGTON - The Food and Drug Administration (FDA) said a novel Medtronic Inc. heart valve that can be implanted without open-heart surgery met study goals looking at safety and effectiveness, but the agency raised concerns about stent fractures seen in some patients.

The device, designed to be implanted into patients through a small catheter that's inserted in the body, is designed to replace the pulmonary valve. The Melody transcatheter pulmonary valve is scheduled to be reviewed Wednesday by the FDA's circulatory system devices panel, composed of outside medical experts. The panel will vote on whether it thinks the device should be granted a humanitarian device exemption, or be approved for use in 4,000 or fewer patients annually.

The valve was studied in a small group of patients who were born with a heart defect that disrupts the blood flow from the heart's right ventricle to the pulmonary artery that leads to the lungs. Patients with such heart defects typically require several open-heart surgeries to replace heart valves.

The FDA said a study involving 99 patients met safety and effectiveness study goals when measured at six months.

The agency, however, said stents that are part of the Melody device fractured in 18 percent of patients in the study. The FDA said data from the United Kingdom, where the device is currently approved, showed a 20 percent fracture rate. The FDA, however, said there's a "low probability" that fragments resulting from fractures would cause blood clots.

DOW JONES NEWS SERVICE