Edwards Lifesciences Halts Use of Artery Patch After Flaw Found

Edwards Lifesciences Corp., the largest maker of replacement heart valves, said Friday it has halted use of its surgical patches for protecting dangerously weakened aortas after spotting small cracks in the patches.

Routine X-rays of two patients in a trial of the Lifepath AAA Endovascular Graft System revealed the cracks. Neither patient had medical problems as a result of the damaged products.

“Our decision to suspend treatment of new patients is purely precautionary and neither existing patient has experienced any negative graft-related health effects,” said Michael Mussallem, chairman and chief executive of the Irvine-based company.

About 235 patients have received the implantable graft, which is threaded into the aorta to shore up a weakened and bulging section of the body’s main artery. Edwards is studying the device in the U.S. and sells it in Europe and Australia; Medtronic Inc. and Guidant Corp. sell similar patches in the U.S.

The cracks appeared in the tiny wires, called wireform, that run through and reinforce the patch, said Scott Nelson, a spokesman for the company.

Edwards is examining the product to identify the source of the problem and will continue to monitor the two patients. A setback with the product won’t have a significant effect on the company’s financial health, Nelson said.