Cook Incorporated To Begin First U.S. Clinical Investigation Of A Fenestrated AAA Endovascular Graft
July 14, 2004
Bloomington, Ind. – Cook Incorporated is the first company to receive U.S. clearance to begin investigational use of a fenestrated endovascular graft for complex abdominal aortic aneurysms. Company officials announced today that the U.S. Food and Drug Administration has approved investigational use of its Zenith, Fenestrated AAA Endovascular Graft to treat abdominal aortic or aortoiliac aneurysms. The fenestrated device is highly customized to meet the anatomic needs of each individual patient. It incorporates scallops at the top and openings in the graft wall called fenestrations that allow it to be implanted precisely in the aorta across adjacent blood vessels without blocking blood flow through those vessels.
The FDA approved Cook’s investigational device exemption (IDE) application for clinical studies at five U.S. medical institutions involving 25 patients. The Zenith Fenestrated AAA Endovascular Graft, an investigational device not approved for sale in the U.S., is designed to treat patients with complex abdominal aortic aneurysms that cannot be effectively treated with standard endograft technologies. The Zenith fenestrated graft, based on Cook’s U.S. approved Zenith AAA endovascular graft design, already is approved for sale in Australia and is available as a custom device in Europe.
“Cook continues to build on the success of its Zenith AAA endograft technology with the fenestrated graft. This graft is highly customized and designed to treat the five percent to 10 percent of patients who have limited options for treatment due to nonfavorable aortic anatomies,” said Kem Hawkins, president and chief executive officer of Cook Incorporated. “We’re eager to begin enrolling patients in this trial and to explore a less-traumatic treatment for complex AAA cases here as we have elsewhere in the world.”
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 – an aneurysm. If the aneurysm ruptures, the patient is at high risk for death due to internal bleeding.
The current treatment option for patients with complex abdominal aortic aneurysms involving vessels in addition to the aorta is open surgery, which poses a significant health risk for many older patients who also may suffer from other medical conditions such as diabetes or hypertension. Standard endovascular technology, where a tube-like endograft crafted from surgical graft material and stainless steel Z-stent bodies is deployed within the aorta to reduce pressure on the aneurysm, typically is not an option for patients with complex abdominal aortic aneurysms.
The Zenith Fenestrated AAA Endovascular Graft is fabricated from woven polyester vascular graft material hand-sewn to self-expanding Z-stent bodies. It’s customized to meet each patient’s aortic anatomy, which can be challenging due to tortuosity, length or size.
Cook’s fenestrated graft is one of several aortic endovascular therapies using Zenith’s patented Z-stent endograft design. The company also is in U.S. clinical trials with the Zenith TX2 endograft designed to treat aneurysms in the descending thoracic aorta and is developing endografts for use in emergency cases where the aneurysm has already ruptured. To date, more than 14,000 Zenith endografts from Cook have been placed in patients worldwide and more than 1,350 U.S. physicians have received clinical instruction in Cook’s industry-unique Zenith physician training program.
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, medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.