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August 17, 2005

Stopping Killer “Bubbles” --
PENN Surgeons Are Now Using and Teaching a Novel Stent-Deployment Device to Barricade Deadly Aneurysms

(Philadelphia, PA) - Bill Tinker used to drive only in the right-hand lane, fearful that at any moment the large aneurysm in his chest would burst and he’d have a few mere seconds to safely get his car to the side of the road. He didn’t want to kill anyone else while he quickly died from internal bleeding.

The Embreeville (Chester County, PA) resident lived in this constant state of fear for nearly five years before the GORE TAG Device let him truly live again. The 70-year-old had miraculously survived the bursting of an aneurysm in his abdomen back in 1999. Until it ruptured, he had no idea that an aneurysm existed inside his body. He immediately underwent a complicated surgery, which only 5% of patients ever live to talk about.

Later, however, doctors discovered another aneurysm growing in his chest. Fearful he wouldn’t survive another long surgery, they treated him with medication for five long years. “I’d stay in the right-hand lane when driving in case that thing blew. I was always looking over my shoulder to the grim reaper,” explained Tinker.

A little over a year ago, Tinker received more bad news. He found out the aneurysm in his chest was growing at a tremendous rate, and he was told he had about two weeks to live. That’s when he was sent to see Drs. Joseph Bavaria and Jeffrey Carpenter, both surgeons at the Hospital of the University of Pennsylvania. With no other options available, they got Tinker into the end of a clinical trial of the GORE TAG Device - a new, third option beyond complex surgery or medications - to treat descending thoracic aortic aneurysms.

The GORE TAG Device recently received F.D.A. approval and now all physicians who want to utilize it must attend a mandatory two-day clinical training session. Those sessions are being offered at only seven centers across the nation, including the Hospital of the University of Pennsylvania (HUP). Drs. Joseph Bavaria and Jeffrey Carpenter, who were both investigators of the GORE TAG Device multicenter pivotal trial, are now surgical instructors providing U.S. physicians training on this revolutionary, life-saving technology.

“We’re proud to serve as a vanguard in this new treatment option. The University of Pennsylvania Health System has been the regional leader in thoracic aneurysm diagnosis and treatment and all complex aneurysm surgery for more than a decade,” said Joseph Bavaria, MD, a national expert on complex aortic surgery and a cardiothoracic surgeon at the Hospital of the University of Pennsylvania.

So what is a descending thoracic aortic aneurysm and why is it so dangerous? (Click on thumbnail to view full-size image). Jeffrey Carpenter, MD, a vascular surgeon and Director of the Vascular Surgery Lab at HUP explains, “It’s a weakening of the wall of the aorta - the main blood vessel coming from the heart, supplying the whole body - which results in a bulge or ballooning; which like a balloon, if stretched too far, will burst. This is almost always fatal. Patients are typically without symptoms, until the aneurysm bursts.”

Of the more than 15,000 patients diagnosed each year with descending thoracic aortic aneurysms (TAAs), most are unaware that a silent, pain-free “time bomb” could be growing within their bodies - and should it burst, will kill them within minutes due to internal bleeding! Indeed, the telltale aneurysm “bubbles” are typically found only when patients visit their doctors for some other condition. Until now, patients with a descending thoracic aortic aneurysm had only two treatment choices: major open surgical repair or medication. Surgery involves a grueling procedure in which the chest-cavity is opened and blood is rerouted with a heart-lung machine in order to access and excise a portion of the diseased aorta. Medication, to control blood pressure and other factors, is ineffective in some patients.

Now there’s a third option for patients -- a minimally invasive stent-implantation procedure utilizing the new GORE TAG stent-deployment device, a thoracic endoprosthesis manufactured by W. L. Gore & Associates, Inc. Physicians insert the device through an incision in the patient’s groin or lower abdomen and advance a catheter up to the diseased portion of the aorta. Next, physicians release a stent-graft off the catheter, relining the diseased aorta and making a new path for the blood flow - which creates a life-saving barrier between the blood-engorged aneurysm “bubble” and the inside of the aortic vessel.

The GORE TAG Device worked on Bill Tinker. In fact, Tinker’s aneurysm was so large, he now has three of the stents inside of him. Tinker comments, “I can do anything I want to today. So I went from two weeks to live, that was 14 months ago, and now I’m still going.”

The husband, father of five, and grandfather of seven… who is a retired neuroscience researcher… now spends his time with his family, as well as inside a little wood shop doing woodworking and carving. And with his new lease on life, he admits that now, “I do drive now in the left-hand lane.”

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Editor’s Note: Drs. Joseph Bavaria and Jeffrey Carpenter both receive a consultant’s fee from W.L. Gore & Associates, Inc.

For further information and animation on the GORE TAG Device, visit www.goremedical.com.

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.

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.

The University of Pennsylvania Health System includes: 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; Penn 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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