Endologix receives FDA approval for Visiflex delivery system

By E. Janene Geiss

Philadelphia, May 24 - Endologix, Inc. announced Wednesday receipt of Food and Drug Administration approval to begin marketing its next-generation Visiflex delivery system for use with the Powerlink system for the minimally invasive treatment of abdominal aortic aneurysm.

The company obtained approval for this PMA supplement in 56 days, according to a company news release.

The company said it plans to introduce Visiflex in the U.S. market through a controlled launch program to further develop targeted physician feedback and to build inventory, with full commercialization anticipated in the fall of this year.

The Visiflex delivery system is designed to provide improved catheter flexibility for delivery of the Powerlink endoluminal stent graft device.

An integrated radiopaque band marker on the outer sheath and molded component parts are expected to enhance catheter visibility and facilitate smoother withdrawal in difficult anatomies, officials said.

Visiflex has been CE marked and used in Europe in Powerlink procedures, with very positive physician feedback to date, officials added.

Based in Irvine, Calif., Endologix develops and manufactures minimally invasive treatments for vascular diseases.

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