The first European patient with a challenging anatomy has had the Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis implanted, according to W.L. Gore & Associates.
The next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms in patients with difficult anatomies. They include patients with proximal aortic neck angles of up to 90 degrees with a minimum 15 mm aortic neck length and patients with proximal aortic neck angles of up to 60 degrees with a 10 mm minimum aortic neck length.
The new device’s limbs are made of a proprietary ePTFE graft material and a fully supported, nested, nitinol stent, and are designed to prevent kinking and occlusion. Gore also introduced a new delivery system called “active control” with this device. It includes a conformable stent graft, enhanced device positioning and optional angulation control, according to the company. To enhance positioning, the device is deployed partially constrained and the physician has the option to reconstrain the proximal end of the device to aid in achieving optimal device placement. During the deployment process, the physician may use the optional angulation control to angle the device to achieve orthogonal placement to the aortic blood flow lumen and to maximize device conformability and seal.
The procedure took place September 11 at Catharina Hospital in Eindhoven, the Netherlands, by Dr. Marc van Sambeek. The patient was also the first enrolled in an investigator-initiated post-market European registry known as EXCeL (EXcluder Conformable real Life), of which van Sambeek is the principal investigator.
“Before this device, EVAR was reserved for patients whose aorta fell within a standard shape and size,” van Sambeek said in a prepared statement. “The conformability of the new Gore Excluder conformable device in combination with the angulation control of the new delivery system will allow us to offer a less invasive, lower-risk alternative to open surgery to more AAA patients than ever before. The EXCeL registry will track the real-world effectiveness and safety of the device, and I look forward to enrolling additional patients with challenging, highly angulated aortic anatomies and seeing the long-term value of this device.”
The EXCeL registry will enroll 150 patients from up to 11 European sites. Data from the registry will assess safety and treatment success of the device for the treatment of infrarenal AAA in a broad range of anatomic presentations. The device has the CE Mark and is also being evaluated in a pivotal investigational U.S. study, in which the first patient was enrolled on December 19, 2017.