Edwards Lifesciences Halts Sales of Abdominal Grafting Product

Edwards Lifesciences Corp. said Friday it has voluntarily suspended sales and clinical trials of a product that is designed to treat a weakness in the wall of an abdominal artery. The Irvine company said it took the action after discovering that a wire within the Lifepath AAA Endovascular Graft System fractured in two patients. The product is meant to treat abdominal aortic aneurysms, a condition that involves a weakening and ballooning of the wall of the aorta, the body’s main circulatory channel. The fractured wires were discovered in the course of routine X-rays of two patients. They have experienced no symptoms and the grafts are still performing as intended, the company said. The company, which makes and sells products and services to treat late-stage cardiovascular disease, said it has undertaken a review of of all Lifepath AAA cases. The endovascular graft has been sold since January in Europe and Australia, the only countries for which sales have so far been approved. Edwards said the product is a “minimal part” of its business. Edwards Lifesciences was spun off early this month from medical device maker Baxter International.