University of Pennslyvania Health Systems
Office of Public Affairs
399 South 34th Street, Suite 2002, Penn Tower, Philadelphia, PA 19104-5653

Contact:
Jen Miller, (215) 349-5657, jennifer.miller@uphs.upenn.edu

November 10, 2003

New Stent Graft for Thoracic Aneurysms Offered at Penn

University of Pennsylvania Medical Center serves as regional site for national trial

(Philadelphia, PA) – In an important step toward further establishing treatment options for patients with life-threatening aneurysms or trauma involving the aorta, the body’s largest artery, the University of Pennsylvania Medical Center is participating in an FDA-approved clinical trial of the Talent(TM) Thoracic Stent Graft System, manufactured by Medtronics, Inc.

Ronald M. Fairman, MD, Chief of Penn’s Division of Vascular Surgery is the primary investigator for the nation-wide “VALOR” trial, which is taking place at 35 sites across the country with Penn as the only site in the Philadelphia region. Joseph E. Bavaria, MD, Director of Penn’s Thoracic Aorta Surgery and Lung Transplantation Programs, serves as co-investigator at the Penn site.

“This is an extremely important trial, as we will be exploring the safety and effectiveness of a device that could significantly increase the number of treatment options for thoracic aneurysm patients,” said Fairman. “In most instances, treatment options are limited and, as a result, mortality rates high. I’m hopeful that we can establish that this stent is both safe and effective, ultimately providing patients with a new option that could save their lives.”

The procedure involves introducing the stent graft through a small opening in the femoral artery of the leg, and advancing it under fluoroscopic guidance to the site of the thoracic aortic aneurysm or dissection, where it is then deployed. Once placed, the stent graft expands to fit the diameter of the aorta, thereby excluding the aneurysm by providing a new path for blood.

It is estimated that there are more than 21,000 patients diagnosed with thoracic aortic aneurysms yearly in the U.S. A number of these patients also have serious co-morbidities such as coronary artery disease, emphysema, high blood pressure and diabetes that make it difficult – if not impossible – for them to survive open surgical repair, which is the current standard of care. Open surgery is a risky, taxing procedure that can lead to death in many frail and elderly patients and can also be associated with severe complications, such as paraplegia. For those patients considered ineligible for open surgical repair, conservative medical management or “watchful waiting” is often used as a treatment option and can lead to increased mortality and morbidity in many elderly patients.

The TalentTM Thoracic Stent Graft System has been approved for over five years in Europe and has been implanted more than 6,000 times worldwide. The VALOR study is a prospective, non-randomized, multi-center, consecutive trial enrolling patients in three separate study arms:

Patients will be divided into three categories: those diagnosed with thoracic aortic aneurysms who are considered candidates for open surgical repair and who are of low- to-moderate risk of major complications; those patients with Type B thoracic aortic dissections, aneurysms associated with dissections, and pseudoaneurysms; and high-risk/non-surgical candidates: including patients with traumatic thoracic aortic aneurysms – incurred through emergencies such as car accidents – who do not have a complete severing of the aorta.

“The standard operation for thoracic aortic aneurysms is difficult for the patient, requires a lengthy recovery period, and can only be done when absolutely necessary,” said Bavaria. “This new therapy is revolutionary and allows much greater access to aneurysm repair in the chest with better outcomes.”

Talent(TM) Thoracic Stent Graft System. For larger images, click on the pictures.

# # #

Editor’s Note: Drs. Fairman and Bavaria have no financial interest in Medtronic, Inc.

PENN Medicine is a $2.2 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 #2 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 consists of four hospitals (including its flagship Hospital of the University of Pennsylvania, consistently rated one of the nation’s “Honor Roll” hospitals by U.S. News & World Report), a faculty practice plan, a primary-care provider network, three multispecialty satellite facilities, and home health care and hospice.

Release available online at http://www.uphs.upenn.edu/news/News_Releases/nov03/valor.htm