Experts Vote No on Heart Device
From Reuters
Foothill Ranch medical device maker CardioGenesis Corp. failed to win U.S. advisors’ backing Monday for its Axcis device, a laser that blasts tiny holes in the heart to relieve severe, chronic chest pain.
The Food and Drug Administration advisory panel expressed concerns over safety and voted 7 to 2 to recommend against approving the technology, which the maker had presented as a less invasive version of its existing laser product.
With Axcis, doctors can reach the heart through a leg artery. The older device requires surgeons to open the patient’s chest.
The FDA usually follows its panels’ advice.
Panel member Jeffrey Borer urged more study of the device.
CardioGenesis has yet to turn a profit.
