Gore wins FDA approval for modified catheter delivery system

The improved delivery catheter enhances the previous version of the Gore Tag thoracic endoprosthesis by adding a soft flexible tip to the leading end of the delivery system. The soft tip improves flexibility at the wire/catheter interface to facilitate tracking through challenging aortic anatomy. The hub component has also been modified to improve ease of use and durability, the company said.

According to the company, the Gore Tag thoracic endoprosthesis internally relines the thoracic aorta and isolates the diseased segment from blood circulation. The Gore Tag thoracic endoprosthesis is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. The device is inserted by a catheter delivery technique through a small incision in the patient’s groin.

The Gore Tag thoracic endoprosthesis was first approved by the FDA in March 2005 and has been granted regulatory approval in Europe, Japan and South Korea. Gore has already begun distribution of the upgraded delivery system, and plans to have this completed across the US shortly.

David Abeyta, associate of aortic products business at Gore, said: The modification of the Gore Tag thoracic endoprosthesis builds on Gore’s reputation for bringing high quality, innovative technology to the medical community. We look forward to even better patient and physician results through this improved delivery system.