Cook Medical Submits Final PMA Modules to FDA for Zenith

Cook Medical announced it submitted the final module of its premarket approval (PMA) application for the Zenith TX2 Thoracic Aortic Aneurysm Endovascular Graft.

 “Cook’s Zenith TX2 provides patients and physicians with … a safe and effective alternative to open surgery,” Jon Matsumura, principal investigator for the Starz-TX2 trial of the device, said.

Thoracic aortic aneurysms occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon. The Cook Zenith TX2, a reinforced fabric tube that is sized to the length of the aorta and covered, is used to seal off the aneurysm. The device helps to relieve pressure on the aneurysm and reduce the risk of rupture, Cook said. The Zenith is currently available in Europe, Australia and New Zealand. Cook said it expects to launch the product in the U.S. in 2008.