April 15, 2019
Gore's Excluder Conformable AAA Endoprosthesis With Active Control System Now Available Across Europe
April 16, 2019—Gore & Associates announced the availability across Europe of the company's new Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis with Active Control system. This marks the commercial expansion of the device beyond early access and registry sites in Europe.
The device has CE Mark approval for patients with proximal aortic neck angles of up to 90º with a minimum 15-mm aortic neck length or in patients with proximal aortic neck angles of up to 60º with a 10-mm minimum aortic neck length.
According to the company, the Active Control system provides staged deployment that enables physicians to reposition the device, if needed, after initial deployment to achieve optimal device placement before full-diameter expansion.
This endovascular aneurysm repair (EVAR) device features a single balloon that replaces the need for multiple molding and occlusion balloons as well as radial expansion force across the range of EVAR device sizes that enables consistent seating and sealing of grafts.
In Gore's announcement, Professor Marc van Sambeek, MD, Principal Investigator for the EXCeL registry, commented, “Previously, these patients with challenging proximal necks, highly angulated or short necks, have been excluded from EVAR treatment. The controlled conformability of the Gore Excluder conformable AAA endoprosthesis with Active Control system provides physicians with an ideal EVAR solution designed to treat these more complex patients. I also appreciate the opportunity to change the angulation of the delivery device and get an optimal apposition perpendicular to the center lumen line. For more straightforward anatomies, the Gore Excluder AAA endoprosthesis featuring C3 delivery system has proven to be a very good and solid device. In my standard practice, it’s absolutely great.”
Gore advised that the device is limited by law to investigational use in the United States. The Excluder conformable AAA endoprosthesis with Active Control system is currently being evaluated in a pivotal investigational study in the United States that began enrollment in December 2017.