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February 16, 2005

The Hospital of the University of Pennsylvania Begins Clinical Trial of Newest Technology to Treat
Thoracic Aortic Aneurysms

(Philadelphia, PA) – A clinical trial is underway at the Hospital of the University of Pennsylvania (HUP) to study the safety and effectiveness of an endovascular medical device to treat life-threatening thoracic aortic aneurysms. Ronald Fairman, MD, Chief of Vascular Surgery at HUP, is leading the study at Penn and is one of 35 principal investigators in North America to participate in this landmark trial.

Thoracic aortic aneurysms (TAAs) 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.

Each year, more than 20,000 patients in the United States are diagnosed with TAA. Aortic aneurysms – including thoracic and abdominal aortic aneurysms – remain the 13th major cause of death in this country, accounting for nearly 15,000 deaths annually.

“The STARZ-TX2 trial is groundbreaking and excellent news for patients diagnosed with descending thoracic aortic aneurysms,” says Dr. Fairman. “Surgery can be life-threatening for many of these patients and a ‘wait-and-see’ approach is often not an option because patients are at an increased risk of an aortic rupture. A non-surgical approach to treating this life-threatening disease could benefit thousands of lives.”

The clinical trial, called STARZ-TX2 (Study of Thoracic Aortic Aneurysm Repair with the Zenith® TX2 Thoracic TAA Endovascular Graft), is open to patients diagnosed with a descending thoracic aortic aneurysm. STARZ-TX2 will compare the outcomes of patients treated with open surgery to patients treated with the Zenith TX2 Thoracic TAA Endovascular Graft, manufactured by Cook Incorporated. Specifically, the trial will assess device performance, as well as patient survival and aneurysm rupture rates in the surgical and endovascular treatment groups, over a 12-month period. The trial will enroll 275 patients at up to 35 medical institutions in the United States and Canada. Additional trial sites in Japan, Australia and Europe also will participate.

Currently, surgical repair is the standard of care for the treatment of TAAs. Surgical repair requires a surgeon to open the chest cavity, clamp off the aorta and sew a surgical graft in place to prevent an aneurysm from rupturing. Open surgical repairs carry high health risks for many older patients, who may also suffer from other significant medical conditions such as heart disease, lung disease, diabetes or hypertension.

The Zenith 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 into position through the patient’s arteries under fluoroscopy, a one- or two-piece, fabric-covered, 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.

Endovascular treatment of aortic aneurysms has been a common practice for the past 10 years in the United States, Europe and Asia. During that time, significant improvements in treatment outcomes have been observed among patients treated with endovascular devices as compared with standard open surgery. Current endovascular treatments are marketed worldwide for the treatment of abdominal aortic aneurysms.

The major cause of thoracic aortic aneurysms is a hardening of the arteries, a condition in which fatty deposits adhere to the walls of the arteries, which become less elastic and weaker as a result. Major risk factors leading to a hardening of the arteries include smoking and high blood pressure as well as genetics. Other possible causes of TAA include trauma to the aorta and congenital diseases such as Marfan’s syndrome.

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PENN Medicine is a $2.7 billion enterprise dedicated to the related missions of medical education, biomedical research, and high-quality patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation’s first medical school) and the University of Pennsylvania Health System (created in 1993 as the nation’s first integrated academic health system).

Penn’s School of Medicine is ranked #3 in the nation for receipt of NIH research funds; and ranked #4 in the nation in U.S. News & World Report’s most recent ranking of top research-oriented medical schools. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.

Penn Health System is comprised of: its flagship hospital, the Hospital of the University of Pennsylvania, consistently rated one of the nation’s “Honor Roll” hospitals by U.S. News & World Report; Pennsylvania Hospital, the nation's first hospital; Presbyterian Medical Center; a faculty practice plan; a primary-care provider network; two multispecialty satellite facilities; and home health care and hospice.

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