Following the unanimous recommendation in April by its Public Advisory Circulatory System Devices Panel, the U.S. Food and Drug Administration has granted Cook Incorporated clearance to sell its Zenith AAA Endovascular Graft System to physicians in the United States.
The Zenith AAA graft system, a third-generation stent-graft system for the endovascular treatment of abdominal aortic aneurysm (AAA), already has captured major market share positions in Europe, Australia and more than 35 other countries where it has been available commercially for several years. U.S. sales will commence immediately.
"On behalf of the many employees of Cook around the world who have given so much of their time, talent and dedication to make this day possible for our company, I'm very proud to announce that the lifesaving technology of the Zenith AAA graft is now available to U.S. patients," said Kem Hawkins, president, Cook Group Incorporated.
The advanced features of the Zenith AAA system, including suprarenal fixation and a graft design that allows treatment of a wide variety of patient anatomies, have created such demand for Cook's endovascular AAA device that more than 1,000 U.S. physicians already have registered for the training required before they can place the graft in a patient, added David Biggs, director, advanced technology management at Cook Incorporated.
"We expect a similar adoption curve in the U.S. to what we've experienced overseas," Biggs explained. "Once physicians become aware of the potential benefits inherent in the Zenith design, a very large number of them decide to adopt this technology for most, if not all, of their AAA patients."
"The treatment of aneurysmal disease beyond AAA using our advanced Zenith technology will play a large role in the future success of Cook," Hawkins added. "In the coming years, we look forward to helping physicians treat many new types of aneurysm patients that cannot yet enjoy the benefits of endovascular therapies for these dangerous conditions." Hawkins said Cook is developing new AAA graft therapies using the Zenith design that flex to fit a broader range of patient anatomy. Future uses of Cook's Zenith technology also may include grafts designed to treat aneurysms in the thoracic aorta and for use in emergency cases where the aneurysm has already ruptured.
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 a fragile, balloon-like swelling called an aneurysm. Should the aneurysm rupture, the patient is 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 must clamp off the aorta to sew a surgical 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 conditions 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.