Arizona Heart Institute Enrolls First Patient In Anaconda(TM) Investigational Study For The Treatment Of Abdominal Aortic Aneurysm

Main Category: Vascular
Also Included In: Cardiovascular / Cardiology;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 20 Jun 2009 - 0:00 PDT

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Surgeons from Arizona Heart Institute performed the first procedure in the U.S. Anaconda Phase II Study using the Vascutek Anaconda Stent Graft System, an investigational, minimally invasive treatment for abdominal aortic aneurysm (AAA).

Leading the study efforts in the U.S. is Julio Rodriguez-Lopez, M.D., Vascular Surgeon, Arizona Heart Institute and Arizona Heart Hospital, and National Principal Investigator. "The Anaconda Stent Graft System has the potential to treat patients with infrarenal AAAs," said Dr. Rodriguez. "In commercial use outside the U.S. Phase II study, this stent graft has been shown to be flexible and repositionable. These are important features when treating patients with infrarenal AAAs," continued Rodriguez.

Abdominal aortic aneurysm, or "ballooning" of the body's main artery, is a serious condition in which the aorta is prone to rupture often causing sudden death. Studies report that emergent, open surgical repair of a ruptured aortic aneurysm carries a 25 to 50 percent risk of death; however, less invasive endovascular procedures involving stent grafts offer a lower-risk alternative to open surgical repair and are associated with minimal blood loss, faster recovery, shorter hospital stays and decreased risk of death.

"Experience with the device, which has been used commercially in nearly 4000 patients in Europe, has been very positive," said Donald B. Reid, M.D., Fellow of the Royal College of Surgeons, Consultant Vascular Surgeon, and Chairman of Vascular Surgery with Wishaw General Hospital and University of Glasgow, Scotland, U.K., who attended the procedure at Arizona Heart Hospital.

Symptoms of aortic rupture can occur suddenly with severe, sharp pain in the abdomen. Patients who experience these symptoms should seek immediate medical attention. Early detection of aortic aneurysms can prevent sudden death; therefore, patients with a family history of aortic aneurysm or other connective tissue disorders should notify their physician about their risk of aortic aneurysm.

About Arizona Heart Institute

Arizona Heart Institute (AHI) is among the world's leading providers of cardiovascular care and world authority in the endovascular treatment of aortic aneurysm and related pathologies. Founded in 1971, AHI has earned its reputation for excellence by creating a state-of-the-art medical facility that specializes in the prevention, diagnosis and treatment of heart and blood vessel disease. In the 1990s, Dr. Edward B. Diethrich, Founder and Medical Director of Arizona Heart Institute and Arizona Heart Hospital, pioneered the development of the very first stent graft for aortic aneurysms. Since then, this minimally invasive technique has become the gold standard worldwide and has changed the way vascular medicine approaches disorders of the aorta. Through dedication, education and innovation, AHI is leading the effort to eliminate cardiovascular disease and discovering new ways to save lives along the way.

About the Study

The objective of the Vascutek Anaconda Stent Graft System Phase II IDE Study (G030036) is to assess the safety and efficacy of the Anaconda Stent Graft System in patients presenting with AAA, when compared to historical open surgical repair. The study, which is sponsored by Terumo Cardiovascular Systems, Ann Arbor, Michigan, is expected to enroll a total of 180 patients at 20 U.S. sites. The device is manufactured by Vascutek Ltd, a Terumo Company located near Glasgow, Scotland. More information can be found at clinicaltrials.gov NCT00612924.

Source: Arizona Heart Institute and Hospital