Cook is celebrating 1,000 implants of its Zenith fenestrated abdominal aortic aneurysm (AAA) endovascular graft. The Zenith fenestrated endograft, which is in clinical trial in the United States, is currently the only endograft commercially available to treat complex AAA where the graft must allow access to an adjoining blood vessel to be maintained to perfuse vital organs.
According to Cook, the Zenith fenestrated endograft is the first in the world to incorporate tailored fenestrations in its top section. This design breakthrough allows the self-expanding stent-graft to treat aortic and aorto-iliac aneurysms that extend close to the renal and superior mesenteric arteries, which are then stented to reduce the risk of restricting or blocking critical blood flow to the kidneys and bowel. Each fenestrated device is custom-made to suit an individual patient's anatomy by Cook's endograft manufacturing division in Australia.
The Zenith fenestrated device retains suprarenal fixation with anchoring barbs to ensure maximal stability and graft-to-vessel sealing. It features woven polyester graft material that is lightweight, strong and shrink-resistant, and employs the H&L-B One-Shot Introducer System that allows simple, accurate deployment and positioning of the graft.
Dr. Roy Greenberg, director of endovascular therapies at the Cleveland Clinic, and national principal investigator for the Zenith fenestrated study in the US, commented, "Fenestrated endografts for complex aortic aneurysms represent a significant step in the evolution of endovascular repair, offering safe, effective endovascular treatment for diseases affecting the more proximal aorta. As branch technology joins the fenestrated family, the entire aorta falls within the domain of aortic interventionalists."
The company has a Satellite Symposium at this year's event, Chaired by Dr Michael Lawrence-Brown, Perth, Australia, at 12.40pm on Monday 10th April, entitled, "The Cook Zenith fenestrated AAA endovascular graft - Worldwide results after the first 1000 cases." Attendees will hear the latest results and updates from Australia (Dr Michael Lawrence-Brown), Europe (Dr Giovanni Torsello, Münster, Germany) and the US (Dr Roy Greenberg, Cleveland, OH). In addition, the session will finish with a glimpse into the future of fenestrated grafts, which will be presented by Professor Krassi Ivancev, Malmo, Sweden.
"The Zenith fenestrated AAA endovascular graft brings the clinical advantages of endovascular treatment to a new subset of patients with highly demanding aneurysms who previously may not have been candidates for endovascular repair," said Barry Thomas, global leader of Cook's endovascular therapy products division. "The Zenith fenestrated endograft provides physicians with a new option when treating AAA patients who cannot be treated using standard, off-the-shelf endograft components."
Cook boosted by EVAR results
Separately, Cook has applauded two sets of results that show the benefits of EVAR over open repair. A three-year study that appeared in the March 2006 issue of the Journal of Vascular Surgery, examined the Medicare billing record of 28,000 AAAs patients treated in the United States with EVAR or open surgery. The research, which was conducted at the University of Pittsburgh, revealed that the risk of in-hospital death was significantly lower with EVAR: 1.9% compared to 5.2% for open repair.
In addition, follow-up data from the company's US pivotal clinical study, showed that patients treated with the Zenith AAA endovascular graft have a 98.9% rate of survival at 30 days compared with 97.5% for patients who underwent open surgery. Good freedom from AAA-related mortality was maintained for endovascular patients through two years, with 98.9% AAA-related survival of standard-risk patients and 93.8% for high-risk patients.
"As these data demonstrate convincingly, Cook has brought to the industry a reliable device that provides me and other physicians dealing with endovascular aortic aneurysm repair with consistent success in treating diseases affecting the more proximal aorta," said Dr Takao Ohki, chief of vascular and endovascular surgery at Montefiore Medical Center, Albert Einstein College of Medicine, New York. "The results of this Cook US clinical study and the University of Pittsburgh study are yet another reassurance that the Zenith endograft and EVAR will continue to bring positive outcomes for our patients."
"Both the data posted in the Journal of Vascular Surgery and the results from our clinical studies further demonstrate that EVAR is the optimal choice for patients requiring AAA treatment," said Barry Thomas. "With our constant focus on patients, we are proud that EVAR performed in Cook's pivotal study with our Zenith AAA endovascular graft delivers an even higher survival rate for AAA patients than was seen in the University of Pittsburgh study."
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