Cook Incorporated Announces Implant of Zenith TX2 Endovascular Graft at ISET 2005: Graft In Clinical Trials for Thoracic Aortic Aneurysm Repair
January 19, 2005
Miami Beach, Fla. – Physicians from Canada successfully implanted the Zenith TX2 Thoracic TAA Endovascular Graft today during a televised procedure at the International Symposium on Endovascular Therapy (ISET) in Miami Beach. The Zenith TX2 graft is being studied at clinical sites throughout the world for the minimally invasive treatment of thoracic aortic aneurysms.
Drs. Bao Bui and Andrew Benko, interventional radiologists, and Dr. Bertrand Scalabrini, vascular surgeon, from Centre Universitaire de Sante de Sherbrooke, completed the endovascular procedure in less than an hour on an elderly male patient during the live event, which was broadcast to more than 1,000 radiologists at ISET.
“The Zenith TX2 is a very reliable device and its deployment is very predictable as compared to other devices,” said Dr. Bui, who has implanted more than 40 Zenith TX2 devices in patients in Canada, where the device is available for use. “This means we can place the device precisely with ease.”
Each year, more than 20,000 patients in the United States are diagnosed with thoracic aortic aneurysms. Aortic aneurysms – including abdominal and thoracic aortic aneurysms – are a leading cause of death in this country, accounting for nearly 15,000 deaths annually.
Currently, open surgical repair is the standard of care for the treatment of thoracic aortic aneurysms.
The Zenith TX2 endovascular graft is being studied in 135 patients at 35 clinical sites in North America, as well as at 14 sites in Australia, Europe, Asia and Japan. The clinical trial, entitled STARZ-TX2 (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2 Thoracic TAA Endovascular Graft) is designed to study the safety and effectiveness of the Zenith TX2 endovascular device for the treatment of aneurysms in the descending thoracic aorta. The trial compares the outcomes of patients treated with open surgery to patients treated with the Zenith TX2 endovascular graft. The Zenith TX2 Thoracic TAA Endovascular Graft is an investigational device not for sale in the U.S.
Thoracic aortic aneurysms occur when a section of the aorta – the body’s largest artery that carries blood out of the heart and into the organs of the body – weakens and bulges outward like a balloon in the section of the artery that runs down the chest. If an aneurysm grows to the point of rupture, a patient is at high risk for rapid death due to internal bleeding.
“Cook is eager to continue enrolling patients and delivering clinical results in the STARZ-TX2 trial. The medical community is anticipating the availability of non-invasive alternatives to open surgery and Cook is committed to delivering the solution,” said Barry Thomas, global leader of Cook Incorporated’s endovascular therapies division. “Cook’s goal is to build on its reputation of pioneering cutting-edge technologies for the treatment of deadly diseases in the peripheral arteries.”
The TX2 system requires an incision to insert the graft’s hydrophilic, kink-resistant delivery system into the femoral artery in the leg. Once the system is guided through the patient’s arteries under fluoroscopy, a one- or two-piece, fabric-coated, self-expanding stent graft is placed inside the weakened section of the thoracic aorta to relieve pressure on the aneurysm, helping to reduce the risk of rupture.
The world’s largest privately owned medical device manufacturer with international headquarters in Bloomington, Ind., COOK® (www.cookmedical.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.