The Zenith TX2 Thoracic TAA Endovascular Graft is a reinforced fabric tube that is sized to the length of the aorta that needs to be covered to seal off the aneurysm. The graft itself is made of a polyester material like that used in open surgical repair. Standard surgical suture is used to sew the graft material to a frame of self-expanding stainless steel stents, which provide support. The materials used in the Zenith TX2 system have a long history of use in medical implants.

While the Zenith TX2 is not approved for commercial use in the United States, it is used in Asia, Australia and Canada. Several thousand patients have been treated outside the United States for the past six years with the Zenith TX2 Thoracic TAA Endovascular Graft. Patients treated with endovascular devices such as the Zenith aortic graft typically experience less trauma and a much shorter recovery period compared to patients undergoing open surgical procedures.

Enrollment requirements

Patients eligible for the STARZ-TX2 trial must be:

• Diagnosed with aneurysms of the descending thoracic aorta
• A candidate for either surgery or endovascular repair
• At least 18 years old

To receive treatment in the STARZ-TX2 trial, patients must meet specific requirements regarding the type and size of aortic aneurysm in the descending aorta. Other medical inclusion and exclusion criteria may also apply.

The STARZ-TX2 clinical trial will enroll up to 270 patients at 35 sites in the United States and Canada.