European EXCel Postmarket Study Begins for Gore's Excluder Conformable AAA Device

September 17, 2018—Gore & Associates announced the first European patient implantation of its Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis with Active Control system. Gore's next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of AAAs in patients with challenging anatomies.

The Excluder conformable AAA endoprosthesis with Active Control system received European 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.

The patient was the first enrollment in the EXCel investigator-initiated postmarket European registry of the device. The procedure was conducted at Catharina Hospital in Eindhoven, the Netherlands by Professor Marc van Sambeek, MD, who is Principal Investigator of the EXCel registry.

The EXCeL registry will enroll 150 patients at up to 11 European sites. Data from the registry will assess safety and treatment success of the Excluder conformable AAA device for the treatment of infrarenal AAAs in a broad range of anatomic presentations. In January, the company announced the beginning of enrollment in a United States pivotal investigational study of the Excluder conformable AAA endoprosthesis with Active Control system.

In Gore's announcement, Prof. van Sambeek commented, “Before this device, EVAR was reserved for patients whose aorta fell within a standard shape and size. 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.”