Cook Medical wins conditional approval to start Zenith endovascular graft study

Cook Medical said that the trial, which will include 24 sites, is designed to evaluate the safety and effectiveness of the smaller endograft delivery system in 120 patients, enabling the endovascular treatment of abdominal aortic aneurysm (AAA) patients with smaller vascular access vessels who otherwise may not have been candidates for minimally invasive endovascular treatment.

Employing a 16-French delivery sheath, the Zenith low profile AAA endograft system is significantly narrower in diameter than the current system used by Cook and other companies, which is 20- to 24-French, according to Cook Medical. This advanced delivery system enables physicians to reduce the need for a surgical cut down to access the femoral artery for device insertion, thereby allowing the use of the less-invasive percutaneous entry technique in many cases, the company added.

Phil Nowell, global leader of Cook Medical’s aortic intervention strategic business unit, said: “We look forward to initiating this trial that brings greater precision and ease of delivery to endovascular aortic repair (EVAR). This major advance in EVAR technology furthers our commitment to developing innovative devices that bring minimally invasive treatment options to all patients suffering from aortic disease.”