Experimental COOK Device Successfully Treats Australian Patient With Torn Aorta.

BLOOMINGTON, Ind. -- A 50-year-old male patient suffering one of the most deadly types of aortic diseases was saved using a unique new medical device combination under development by Cook Incorporated. The patient was admitted with crushing chest pain at Monash Medical Centre in Melbourne, Australia and diagnosed with an aortic dissection, the same tearing of the body's main blood vessel that killed American actor John Ritter.

Blood flow to the extremities was so weak, physicians thought the patient might lose both legs and the left kidney even if treatment of the dissection was successful. To repair the leaking aorta and restore adequate blood flow, vascular surgeon Terry Devine, M.D., assisted by Greg Self, M.D., deployed the proximal part of a Cook Zenith TX2 TAA Endovascular Graft over the torn section of the thoracic aorta to seal off the tear, allowing blood pumped from the heart to once again flow through the aorta to the rest of the body.

Some reduction in blood flow remained due to compression of the abdominal aorta, which was caused by trapped blood in the vessel wall resulting from the tear. Dr. Devine resolved this by placing the Zenith Dissection Stent, developed by Peter Mossop, M.D., and Ian Nixon, M.D., at St. Vincent's Hospital in Melbourne in conjunction with Cook, in the aorta along the length of the compressed section.

After placement of the TX2 and the dissection stent, Dr. Devine reported that blood flow was restored, the kidney had normal circulation and both legs displayed strong pulses. A post-procedural CT scan confirmed that the Zenith device had successfully treated the aortic dissection, hospital officials said. The patient was discharged one week after the procedure and went home.

"Success with this patient demonstrates that similar work by pioneers Dr. Mossop and Dr. Nixon of Melbourne in treating aortic dissections with endografts and stents is both viable and repeatable," reported Barry Thomas, global leader of Cook's endovascular therapy products division that developed the Zenith TX2 Endovascular Graft and dissection stents. "Dr. Devine told us that in his opinion, this case demonstrated that endovascular repair of aortic dissection does work, and added that he will be treating the next Type B dissection he sees using this revolutionary technique."

Endovascular aortic repair eliminates the need for highly invasive open surgery. Rather than opening the chest cavity and clamping off the aorta to surgically implant a graft to treat the damaged section of aorta, physicians insert a catheter loaded with a self-expanding, fabric-covered stent-graft through a surgical opening in the femoral artery. The catheter is guided through the patient's blood vessels under fluoroscopy until the device is positioned across the diseased or injured section of the aorta. The stent-graft expands upon deployment from the catheter to form a continuous tube through the aorta that carries the blood and reduces pressure on the damaged vessel, restoring normal blood flow.

Cook is the only company in the world at this time exploring the possibility of using stents and endografts to repair aneurysms and dissections throughout the entire aorta, a development that could save tens of thousands of lives annually.

Its Zenith AAA Endovascular Graft is the world's best-selling endovascular system for treating abdominal aortic aneurysm and is approved for sale in Europe, Australia and the United States. The Zenith TX2 Endovascular Graft is approved in Australia and Europe for treating thoracic aortic aneurysms, dissections and trauma and the STARZ-TX2 clinical trial of the device is underway in the U.S. now. The combination of endograft and stent for treating aortic dissection is under clinical investigation in Australia, and a U.S. clinical trial for that indication is expected to begin this year. The U.S. trial's national principal investigator is Joseph Lombardi, M .D., chief of vascular surgery, Methodist Hospital Division of Thomas Jefferson University Hospital in Philadelphia, Penn.

The Zenith TX2 TAA Endovascular Graft is an investigational device not approved for sale in the United States at this time.

The world's largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOK(R) (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 drug-eluting and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and OB/GYN, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.