Cook Initiates Study of Zenith Low Profile AAA Graft
June 11, 2009—Cook Medical (Bloomington, IN) announced that it has initiated enrollment in a clinical trial of its Zenith Low Profile (LP) abdominal aortic aneurysm (AAA) endovascular graft. The trial is evaluating the safety and effectiveness of the small endograft delivery system in 120 patients at 24 sites in the United States. Ronald Fairman, MD, is the trial's principal investigator. The Zenith AAA LP is an investigational device not approved for sale in the United States, the company advised.
According to Cook Medical, the study is intended to establish the clinical benefits of endovascular aneurysm repair (EVAR) for patients whose vascular anatomies are unsuited to the larger-diameter devices currently in use. By reducing the diameter of the delivery system to 16 F and eliminating the need for a top cap to ensure precise delivery of the device to the target location, the Zenith AAA LP is a reinvention of Cook's Zenith Flex AAA endograft system. If proven safe and effective, the new system could make EVAR possible for a greater population of AAA patients, particularly women and Asian patients who tend to have narrower, more tortuous vessels that current AAA endografts may have difficulty navigating safely, stated the company.
"While EVAR has become the preferred treatment method for AAA in most cases, patients with smaller vascular anatomies had few, if any, treatment options outside of highly invasive open surgery," commented Mark Farber, MD, who performed the first placement of the Zenith AAA LP. "With the new Zenith LP AAA graft, physicians can now provide this challenging patient population with the solution of choice for treating AAA. The Zenith LP creates more options for my patients that in the past could not have the endovascular procedure."