Cooper University Hospital will take part in a clinical trial of the first medical device designed to specifically treat aortic dissections, an often-fatal condition that affects tens of thousands in the U.S. and claimed the life of actor John Ritter.
Recognized as a preferred treatment center for the minimally invasive treatment of aortic diseases, Cooper was approved by the hospital’s institutional review board (IRB) for its involvement in the study. This approval follows the recent appointment of the trial’s global principal investigator, Joseph V. Lombardi, M.D., FACS, as chief of vascular and endovascular surgery at Cooper and associate professor of surgery at the Robert Wood Johnson Medical School, University of Medicine & Dentistry of New Jersey.
Cooper joins an international network of study sites in Cook Medical’s STABLE aortic dissection trial, intended to evaluate a novel procedure, called the Cook Zenith® Dissection Endovascular System that could replace costly and invasive open surgery to restore normal blood flow in damaged aortas. The new technique would reduce risk, speed recovery time and improve the quality of life for patients who experience complications in Type B dissections, which occur in the descending aorta.
“Given its reputation amongst the medical community as a leader in aortic repair, Cooper represents a natural fit for the STABLE aortic dissection trial,” said Dr. Lombardi. “The trial has already made great progress in advancing minimally invasive treatments for thoracic aortic dissections, and by bringing the trial to Cooper University Hospital, we anticipate building upon that success to achieve even greater results.”
One in 5,000 people in the U.S. will suffer from an aortic dissection, a tear in the wall of the major artery that carries blood out of the heart. Some dissections can be treated with blood-pressure medication, but many require surgical intervention, which traditionally involves opening the chest cavity, clamping off the aorta, and implanting a graft that repairs the damaged vessel wall. In the trial technique, called endovascular aortic repair (EVAR), physicians insert a catheter loaded with a self-expanding, fabric covered stent-graft through a surgical opening in the femoral artery of the leg. The catheter is guided through the patient’s blood vessels under fluoroscopy until the stent is positioned across the weakened section of the aorta. The stent-graft expands upon deployment to form a continuous tube through the aorta that carries the blood and reduces pressure on the damaged vessel.
“The expansion of the STABLE clinical trial to Cooper University Hospital is a major step forward in providing the best possible care for patients suffering from thoracic aortic dissections,” said Phil Nowell, global director of Cook’s Aortic Intervention strategic business unit. “We are excited that Dr. Lombardi will continue his work at Cooper University Hospital to help advance treatment for patients suffering from the condition.”
The current trial, which began in December 2007, is the first and only to focus on the endovascular treatment of Type B aortic dissection. The Cook Zenith Dissection Endovascular system comprises two components: Cook’s Zenith TX2 Endovascular Graft, which seals the torn aortic section, and a second, uncovered stent that helps to support the true lumen of the aorta and promote apposition of the dissected vessel wall. The Zenith Dissection Endovascular System is an investigational device not available in the United States. The TX2 is already approved in the United States, Europe, Australia and New Zealand for the treatment of thoracic aortic aneurysms and dissections.
Dr. Lombardi treated the first U.S. patient enrolled in the STABLE clinical trial, a 79-year-old male, during his tenure as Director of the aortic center at Thomas Jefferson University Hospital. He oversees treatment at other STABLE study sites including the University of Florida in Gainesville, Fla., Massachusetts General Hospital in Boston, Mass, and at institutions in Europe and Australia.
About Cooper University Hospital
Cooper University Hospital is the flagship of The Cooper Health System. It is the premier university hospital serving South Jersey and the Delaware Valley. As the core clinical campus for the Robert Wood Johnson Medical School in Camden, Cooper is a national leader in medical education and research. With its comprehensive services and cutting-edge technology, the hospital is renowned for its prestigious Centers of Excellence in cardiology, cancer, critical care, trauma, orthopedics and neurology. Cooper has embarked on a $500 million expansion of its Camden Health Care Campus including a new $220 million patient Pavilion which opened in December 2008. Cooper and its community partners earned a 2008 Smart Growth Award from New Jersey Future for the vision of the Health Sciences Campus in Camden.
About Cook Medical
Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy, and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963 and operated as a family-held private corporation, Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.
Media Contacts for Cook Medical and Racepoint Group
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812-339-2235, ext. 2387
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Racepoint Group
781-487-4625
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