FDA Panel Unanimously Approves Cook's Zenith® AAA Endovascular Graft
April 10, 2003
Bloomington, Ind. – By a vote of eight to zero, the Zenith® AAA Endovascular Graft System, a third-generation stent-graft system for the endovascular treatment of abdominal aortic aneurysm (AAA) from Cook® Incorporated, received unanimous approval from the U.S. Food and Drug Administration’s Public Advisory Circulatory System Devices Panel today.
The panel added a number of conditions to its approval, including the exclusion of isolated iliac aneurysms from the indications for use and the establishment of five-year follow-up surveillance on the patients included in Cook’s U.S. pivotal trial of the device.
“The employees of Cook Incorporated who have devoted so much time, talent and tenacity to developing the Zenith graft system are very gratified by the FDA review panel’s favorable decision today,” said Kem Hawkins, president of Cook Incorporated. “This device, which has proven itself clinically in thousands of cases in Australia, Europe and in clinical trials in the U.S., offers physicians and their patients the world’s most evolved, highly developed endovascular system for treating aortic aneurysms. We look forward to working with FDA in completing the review process and making this system available soon.”
The Zenith AAA Endovascular Graft System goes beyond the endovascular AAA systems currently available in the U.S. with its suprarenal fixation and graft design that allows treatment of a wide variety of patient anatomies. 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.
Testifying during the public comment period of the hearing was former U.S. Senator Bob Dole, who was treated with a Zenith endovascular graft when his abdominal aortic aneurysm was discovered in June 2001. “I’m not here today to endorse a specific product, I’m just here to tell my story and I’m happy to be here today,” said Senator Dole, whose own father died of an aortic aneurysm.
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 permits treatment of these aneurysms without the need for major open 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 stent-graft is deployed inside the weakened section of the aorta and the surrounding vessels to relieve pressure on the aneurysm, greatly reducing the risk of rupture.
With international headquarters in Bloomington, Ind., privately held COOK® (www.cookgroup.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for stents and stent-grafts, catheters, wire guides, introducer needles and sheaths, embolization coils, tissue-engineered medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.
Sign up here to receive e-mail from Cook on clinical updates, new product details and educational opportunities.
Sign Up »