W L Gore & Associates (Gore) has obtained Shonin approval from the Japanese Ministry of Health, Labor and Welfare to market the Gore Excluder AAA endoprosthesis, comprising the new Gore C3 delivery system, for treating patients suffering from an abdominal aortic aneurysm (AAA).
The device is designed to give physicians two additional opportunities to accurately place the stent-graft relative to the patient’s anatomy.
This innovation enables physicians and interventionalists to reposition device for ideal placement in treating AAA, while offering the physicians the best possible deployment of the stent graft relative to the patient’s anatomy.
This next-generation delivery system has the potential to make endovascular repair easier in challenging anatomy.
The Gore C3 delivery system provides physicians with a proven stent-graft and new delivery system, which was previously unavailable in Japan.
Once delivered into the aorta, the Gore C3 delivery system intuitively enables repositioning of the stent-graft.
The ability to reposition the device may minimise complications that could occur if the graft needs to be repositioned after the initial deployment.
The Gore Excluder device remains virtually unchanged, with the same low delivery profile and flexibility on catheter that facilitates access and passage through narrow and tortuous anatomies.
Methodist Hospital chair department of cardiovascular surgery Houston Texas Dr Alan Lumsden said the Gore C3 delivery system offers more opportunities to optimise infrarenal seal and provides the physician with greater control.
"The ability to reposition minimises complications that can occur with graft placement, adding a level of confidence and control during endovascular procedures that physicians have not experienced before," Dr Lumsden said.
This technology received the US Food and Drug Administration (FDA) approval in January 2011.
Gore Aortic Business Leader Ryan Takeuchi said since launching the Gore C3 delivery system for the Gore Excluder device in 2011, it has shown a high-level of performance.
"Through our innovative designs and close collaboration with the endovascular community, Gore aims to bring safe and effective minimally invasive endovascular repair to patients worldwide," Takeuchi said.
According to GlobalData estimates, the abdominal aortic stent grafts market in Japan was valued at $122.6m in 2012 and is expected to grow at a CAGR of 3.2% to reach $153m by 2019.