BOSTON – Vascular surgeons at Massachusetts General Hospital (MGH) treated the first patient in New England in the Ventana U.S. Clinical Trial last week. MGH is one of 25 sites in the U.S. chosen to participate in this prospective, multicenter research study approved by the U.S. Food and Drug Administration to evaluate the safety and effectiveness of the Ventana™ Fenestrated System for the endovascular repair of juxtarenal (JAA) and pararenal (PAA) aortic aneurysms. The procedure, led by Christopher Kwolek, MD, program director for the MGH Vascular and Endovascular Fellowship Program and principal investigator of this trial in the Massachusetts General Hospital Vascular Center, and Mark Conrad, MD, MMSc, assistant professor of surgery at MGH, was performed to treat the patient’s abdominal aortic aneurysm (AAA) which was encroaching on the arteries to the patient’s kidneys. This condition can be life threatening for patients, who often experience no symptoms before a rupture occurs. AAA is the 13th leading cause of death in the United States, causing about 15,000 deaths annually.
"We are thrilled to be the first site in New England to use this stent graft device in our patients with complex abdominal aortic aneurysm," says Kwolek. "This ‘off-the-shelf’ stent graft system will allow surgeons to move away from complex open procedures when treating these more complex AAAs, and this less invasive approach is expected to result in fewer complications in surgery and speed up the recovery process for patients. In addition, these premade grafts can sit on the hospital shelf and are flexible enough to treat the majority of patients with complex anatomy. Currently these patients require either an open operation through a large flank incision or the use of a custom made device which can take over 8 weeks to manufacture and ship."
An estimated 20 percent of AAA patients including those that are near or involve the renal arteries are not treatable with any other approved stent graft device in the United States. The trial, sponsored by Endologix, Inc. (Irvine, CA), will involve up to 122 patients. For more information about the trial, visit www.clinicaltrial.gov and enter NCT01491945. For more information about AAAs, click here.
Massachusetts General Hospital (www.massgeneral.org) is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of nearly $700 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, reproductive biology, regenerative medicine, reproductive biology, systems biology, transplantation biology and photomedicine.