Cook Medical's New Zenith[R] TX2[R] TAA Endovascular Graft With Pro-Form[TM] Enhances Control During Thoracic Aneurysm Repair.

BLOOMINGTON, Ind. -- Physicians performing thoracic endovascular repair (TEVAR) now can achieve even greater levels of control during endograft deployment compared to the original TX2 device with Cook Medical's new Zenith[R] TX2[R] TAA Endovascular Graft with Pro-Form[TM]. Cook's new TX2 Pro-Form endograft, which has now obtained FDA approval, utilizes an improved delivery system that allows for carefully controlled deployment of the endograft to help establish proximal conformity of the device to the aortic wall. This innovation in endovascular TAA repair was engineered especially for procedures in which endografts must be positioned in tight aortic arches that are notoriously difficult to seal properly.

"Cook is committed to being the technological leader in advanced devices for the treatment of aortic disease from the arch to the iliacs," explained Phil Nowell, global business unit leader for Cook Medical's aortic intervention division. "Many physicians are familiar with the relatively common problem of thoracic endografts forming a 'bird's beak' gap along its underside when the graft is deployed into a tight aortic arch. With FDA approval of the Zenith TX2 TAA Endovascular Graft with Pro-Form, Cook is bringing an even more advanced version of its thoracic device to the U.S. market that addresses the need for highly controlled deployment, one of the most significant issues facing physicians performing TEVAR today."

Thoracic aortic aneurysms (TAAs) occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon, often caused by a hardening of the arteries, high blood pressure or trauma. Aneurysms in the thoracic aorta can result in severe internal bleeding and are potentially fatal; untreated, five-year survival is estimated at between 10 to 15 percent. Moreover, in approximately 25 percent of TAA patients, the aortic arch, which is formed like a reversed U, is exceptionally tight, making treatment difficult.

Many earlier endografts were too rigid or possess sealing stents that lack the radial force to conform correctly to the inner curvature of tight aortic arches, preventing the graft from properly sealing off the aneurysm. Consequently, surgeons have historically been forced to remodel the arch with a balloon or use other aids to position the graft, in an effort to reduce the risk of continued bleeding into the aneurysm and possible rupture. As a result, these difficult repair procedures are often long and complex. The TX2 Pro-Form's enhanced delivery system may mitigate the need for such additional measures.

TEVAR - A Minimally Invasive Alternative to Open Surgery

Historically, open surgical repair has been the standard treatment for TAAs. Under this approach, the chest cavity is opened and the aorta is clamped, allowing the surgeon to sew a surgical graft into place to prevent a rupture. Open surgery for TAA can lead to serious complications and extended recovery times and also has a higher patient mortality rate than endovascular repair.

With TEVAR, a minimally invasive alternative to traditional, open surgery, an endograft is guided into the body by a catheter to seal off the aneurysm from within. Patients undergoing TEVAR typically experience shorter recovery times, less patient discomfort and are also at a lower risk of the co-morbidities associated with open surgical repair. In particular, the Zenith TX2 device is inserted through a small incision in the groin to access the patient's femoral artery. The device is guided into position through the patient's arteries under fluoroscopy. The fabric-covered self-expanding stent-graft is then placed in the weakened section of the thoracic aorta to relieve pressure on the aneurysm to reduce the risk of rupture. For more information, visit www.zenithstentgraft.com.

About Cook

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963 and operated as a family-held private corporation, Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.