Bloomington, Ind., October 8, 2009 — For the first time in Australia, surgeons at the Royal Brisbane and Womens' Hospital have successfully treated a patient with an innovative new endovascular graft to repair a difficult thoracic aortic aneurysm.

Cook Medical's newly approved Zenith® TX2® TAA Endovascular Graft with Pro-Form™ achieves better proximal conformity to the aortic wall than earlier versions of the device, minimising the risk of a 'bird's beak' gap forming.

In complex cases where the arch of the aorta is tight, previous devices could allow a 'bird's beak' gap to remain between the underside of the graft and the aorta wall, compromising their effectiveness and increasing the risk of leaks into the damaged section of aorta wall.

“The new device is a significant advance on the previous generation of devices,” said Dr Jason Jenkins, the vascular surgeon who conducted the procedure.

“In the past we were unable to achieve good wall apposition in some patients with difficult arch anatomy. This device, because of its change in design, has allowed significantly better wall contact with the graft and therefore may decrease the incidence of endoleak and bird beaks gap,” he said.

The patient, an elderly woman, suffered from a large thoracic aortic aneurysm and was difficult to treat due to a tightly angled aortic arch.

“This was a difficult aneurysm that was successfully excluded and was certainly made easier with a TX2 Pro-Form device,” Dr Jenkins said.

While the TX2 Pro-Form™ device is useful for many patients with TAA, it may enable people who were previously excluded from treatment to receive the potentially life saving procedure, Cook reported.

“I think it will allow us to actually have shorter landing zones to deploy in the arch,” Dr Jenkins said, “This will potentially enable us to treat more patients”.

A thoracic aortic aneurysm occurs when a section of the aorta becomes stretched and forms a weakened, balloon-like area. A burst aneurysm often results in severe internal bleeding and is fatal in up to 80 per cent of cases.

Aneurysms in the aortic arch above the heart can be difficult to seal properly, as 25 per cent of patients have a tight aortic arch.

Cook's TX2 Pro-Form™ uses an improved delivery system that allows for a more carefully controlled deployment and may result in reduced procedural time. This enhanced control allows the surgeon to precisely deploy the graft so it is better aligned with the patient's aorta.

“The new Pro-Form device allowed more accurate deployment of a proximal stent particularly with alignment on the inner curve of the aortic arch where normally 'bird-beaking' becomes a major problem with the acutely angled aortic arch,” said vascular surgeon Dr Nick Boyne.

“I think it certainly increases the accuracy and safety of deploying these grafts in acutely angled patients. The real benefit will be in treating aneurysms in the tight aortic arch, particularly the acute traumatic transections where the issue of bird-beaking is a major concern,” he said.

Phil Nowell, global business unit leader for Cook Medical's aortic intervention division, said the innovative delivery system offers patients unparalleled safety in endovascular TAA repair.

“The Zenith TX2 TAA Endovascular Graft with Pro-Form is an even more advanced version of its thoracic device that addresses the need for highly controlled deployment, one of the most significant issues facing physicians performing thoracic endovascular aortic repair today,” Mr Nowell said.

Notes:

A thoracic aortic aneurysm (TAA) occurs when a section of the aorta becomes stretched and forms a weakened, balloon-like area. A burst aneurysm results in severe internal bleeding and is often fatal.

Endovascular aneurysm repair is where an endovascular graft – a tubular fabric device supported by self-expanding metal stent bodies – is guided into the body with a catheter.

Once inserted into the aorta, the endovascular graft seals off the aneurysm from within, relieving blood pressure against the weakened walls of the aorta, the body's main blood vessel, and reducing the risk of rupture.

The alternative treatment is open surgery, which requires a general anaesthetic and the creation of a large incision in the chest to allow a surgeon to clamp off the thoracic aorta and replace the damaged section with a surgical graft, can lead to serious complications and extended recovery times.

About Cook Medical
Cook Medical helped invent and popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures throughout the body's vascular, gastrointestinal, respiratory, urological and OB/GYN pathways. 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 radiology; critical care medicine; gastroenterology; peripheral vascular medicine; bone access and oncology; interventional cardiology; general surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963, Cook Medical operates as a family-held private corporation focused on providing superior patient outcomes while reducing health care delivery costs. For more information, visit www.cookmedical.com. You may sign up to follow Cook Medical on Twitter at http.www.twitter.com/cookmedicalpr.