Healthcare Industry News:  Cook 

Devices FDA

 News Release - July 31, 2006

Cook Incorporated Completes Enrollment of Patients in STARZ-TX2 Trial

Study Results on Zenith(R) TX2(TM) Endovascular Graft for Thoracic Aortic Aneurysms To Be Submitted for FDA Approval

BLOOMINGTON, Ind.--(HSMN NewsFeed)--July 31, 2006--Cook Incorporated has completed patient enrollment in the STARZ-TX2 clinical trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith® TX2(TM) Thoracic TAA Endovascular Graft) and is preparing data for submission to the Food and Drug Administration (FDA) later this year.

The STARZ-TX2 trial, which enrolled more than 200 patients at 39 clinical sites around the world, studied the safety and effectiveness of Cook's Zenith TX2 Thoracic TAA Endovascular Graft for the treatment of thoracic aortic aneurysms.

"As a world leader in endovascular stent-graft and stent design and technology, Cook is eager to introduce its newest Zenith device to the U.S. marketplace for the treatment of thoracic aortic aneurysms," said Barry Thomas, global leader of Cook's endovascular therapies division. "The Zenith TX2 device incorporates the fundamental design elements that have made the Zenith endograft the world's most widely used endovascular device for treating aortic aneurysms and we're eager to provide U.S. patients and physicians this new Zenith technology for thoracic aortic aneurysm repair."

The STARZ-TX2 trial compares the safety and effectiveness of the Zenith TX2 endovascular device for the treatment of aneurysms in the descending thoracic aorta to traditional open surgery. The trial is assessing device performance, as well as patient survival and rupture rates over a 12-month period. While Cook now has enrolled enough patients to fulfill the study criteria, 11 clinical trial sites in North America are still providing thoracic aortic aneurysm treatment with the Zenith device to patients through continued access.

Thoracic aortic aneurysms occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon. Historically, surgical repair has been the standard treatment. During surgery, the chest cavity is opened and the aorta is clamped, allowing the surgeon to sew a surgical graft into place to prevent a rupture. Surgical repairs may carry health risks for older patients as they likely suffer from other significant medical conditions.

Endovascular repair shows promise for treatment of thoracic aortic aneurysms because it's less invasive and may result in fewer complications and quicker recovery. The Zenith TX2 device is inserted in a small incision near each hip to access the patient's femoral artery. The device is guided into position through the patient's arteries under fluoroscopy. The fabric-covered self-expanding stent-graft is placed in the weakened section of the thoracic aorta to relieve pressure on the aneurysm to reduce the risk of rupture.

All patients enrolled in the STARZ-TX2 trial are being evaluated at regular intervals during the 12 months following either insertion of the Zenith TX2 or open surgery. Patient data will continue to be monitored regularly.

Each year, 15,000 patients in the United States are diagnosed with thoracic aortic aneurysms. Aortic aneurysms - including abdominal and thoracic aneurysms - are a leading cause of death in the United States.

While the Zenith TX2 is not yet approved for commercial use in the United States, it is approved for sale in Europe, Australia, Brazil, Thailand, Singapore, Argentina, Peru, Mexico, Columbia and New Zealand. Several thousand patients have been treated outside the United States for the past six years with the Zenith TX2 Thoracic TAA Endovascular Graft.

Note: The Zenith TX2 Thoracic TAA Endovascular Graft from Cook Inc. is an investigational device not yet available for sale in the United States.

The world's largest privately held 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.


Source: Cook Inc

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