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Biomed Execs, Scientists Form Consultancy; Autism Center Opens
Officials at Edwards Lifesciences Corp., Irvine, traveled to Lucerne, Switzerland, in recent weeks to participate in the European Society for Vascular Surgery's annual meeting. While at the meeting, they announced Edwards had received CE-mark approval to market its Lifepath AAA endovascular graft system within the European Union.
The Lifepath that was just approved is a next-generation version. Edwards said the new Lifepath features design enhancements to meet stringent requirements for treating aneurysms, determined through experiences with previously available therapies, including Edwards' original Lifepath.
Lifepath is a treatment system for abdominal aortic aneurysm that uses a catheter device to place a permanent graft that reinforces the wall of the aorta in the affected area. Edwards officials voluntarily suspended selling the original Lifepath AAA product outside of the U.S., as well as U.S. and European clinical trials, in April 2000, after some cases in which the device's wireform support for the graft fractured.
After Edwards suspended the original Lifepath product, it conducted a review, redesign and retesting process before seeking the CE mark for the new system.