W L Gore & Associates (Gore) recently announced that the US Food and Drug Administration (FDA) has granted regulatory approval for the new Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis with Active Control system.
According to a press release, the device is a new endovascular aneurysm repair (EVAR) solution which builds on the proven clinical performance of the Gore Excluder AAA endoprosthesis and incorporates design elements similar to the conformable Gore Tag stent graft.
In addition, the Gore Excluder conformable device debuts the Gore Active Control system into the abdominal aorta and is comprised of a conformable stent graft, enhanced device positioning, and optional angulation control. This delivery system is the first to feature angulation control, giving physicians the option to angle the device to achieve orthogonal placement to the aortic blood flow lumen to maximise conformability and seal.
“I am impressed with how well the device performed in the clinical study and appreciate the efforts of the investigators who contributed to this milestone,” said Robert Rhee (Maimonides Medical Center in New York, USA), national principal investigator.
“The data submitted to the FDA included 100% technical success, 100% freedom from device related serious adverse events, and 100% patency.” The data Rhee referenced is from the first sub-study of the clinical trial, which enrolled 80 patients who completed one-year follow-up. The second sub-study of the trial will evaluate the device in proximal aortic neck angles of >60 to 90 degrees and aortic neck lengths of 10mm or greater. Enrolment in this sub-study is ongoing.
“Additionally, there were no type I/III endoleaks, migration, rupture, conversion to open repair, stent fractures, or limb occlusions, and 98.6% of patients showed freedom from aneurysm enlargement.” said Rhee. “I am confident this device will expand EVAR treatment options for patients diagnosed with AAAs. The Gore Excluder conformable AAA endoprosthesis with Active Control system received CE mark in 2016.