The Zenith AAA Endovascular Graft System, a third-generation stent-graft system for the endovascular treatment of abdominal aortic aneurysm (AAA) from Cook Incorporated, has received a device license from Health Canada, officials at Cook (Canada) Inc. confirmed.
"This is a very exciting development, not just for the Cook organization, but also for abdominal aortic aneurysm patients in Canada who now can benefit from the advanced features of the Zenith AAA Graft," said Bill Bobbie, president, Cook (Canada) Inc. "We believe the clinical benefits of the Zenith system will quickly allow it to become the device of choice for the endovascular treatment of AAA in Canada."
The Zenith AAA Graft System goes far beyond the first-generation endovascular AAA systems currently available by including advanced features to improve fixation and reduce the likelihood of stent-graft leakage, problems seen in earlier AAA devices marketed in the U.S. and elsewhere. Developed jointly by Cook companies in the U.S., Europe and Australia, the Zenith system has been clinically shown to lower morbidity rates, reduce recovery time and improve quality of life for patients undergoing endovascular AAA repair compared to open surgical procedures.
"Cook's Zenith AAA endovascular graft takes advantage of the latest research and development breakthroughs in treating patients with abdominal aortic aneurysms," explained David Biggs, director, advanced technology management at Cook Incorporated. "Physicians around the world have recognized our system's many advantages and design innovations and have adopted the Zenith device enthusiastically."
Abdominal aortic aneurysm is a life-threatening condition that occurs when a section of the abdominal aorta, the body's main circulatory vessel, weakens and bulges outward to form an aneurysm. Should the aneurysm rupture, the patient would be at high risk for death due to internal bleeding. Patients diagnosed with AAA traditionally have had to undergo an open surgical procedure requiring an incision the full length of the patient's torso and the exposure of the body's internal organs to reach the aneurysm site. A vascular surgeon then would open the aorta and sew a graft in place to prevent the aneurysm from rupturing. Such open surgical procedures carry significant health risks for many older patients, who may also suffer from other medical risks such as diabetes or hypertension.
Cook's Zenith AAA Endovascular Graft system treats these aneurysms without the need for major surgery. Patients treated with the Zenith system require just two incisions to allow the insertion of two catheters into the femoral arteries in the groin. Once the catheters are guided into position through the patient's arteries, a fabric-covered, self-expanding metal stent-graft is deployed inside the weakened section of the aorta and the surrounding vessels to relieve pressure on the aneurysm.