Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guide the study device(s) into place in the aorta.

Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.

The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.

Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.

There were 8 patients experienced 30-day major complications.

The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.

Rupture was determined as the cause of death. Site reported that it was related to a pre-existing condition and not the device, clinical events committee (CEC) adjudicated that it was procedure and technique related.