News | November 23, 2008

Cook Receives Conditional FDA Approval to Begin Trial for Zenith Low Profile AAA Graft

November 24, 2008 - Cook Medical received investigational device exemption (IDE) conditional approval from the U.S. Food and Drug Administration (FDA) to begin a clinical trial for its Zenith Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft.

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 AAA patients with smaller vascular access vessels who otherwise may not have been candidates for minimally invasive endovascular treatment. The company announced the conditional IDE approval at this year’s VEITHsymposium, a five-day event featuring presentations from world-renowned vascular specialists in New York.

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. 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. With this approach, a needle is inserted into the blood vessel through the skin, allowing the guide wire and delivery sheath to enter the artery with much less blood loss and trauma. Cook said with the Zenith Low Profile, physicians have the opportunity to endovascularly serve an additional subset of patients previously ineligible for endovascular treatment due to anatomical restrictions.

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