Atrium Medical Corporation announced that the 100th patient was enrolled in the iCAST™ Atrium Registry Ultrasound Study (iCARUS). The iCARUS study is a prospective, multi-center clinical trial studying the safety and efficacy of the Atrium iCAST™ Balloon Expandable Covered Stent in patients with occlusive disease in the iliac artery. This first of its kind premounted "balloon expandable covered stent" US trial is approved by the FDA under an investigational device exemption.
Iliac artery occlusive disease is one form of Peripheral Arterial Disease (PAD). PAD affects over 8 million people in the United States. Patients with PAD typically present with symptoms known as claudication or rest pain. Claudication is a sharp cramp like pain in the legs that occurs when walking or exercising. Rest pain is defined as "continued pain" or "painful cramping" of the legs immediately following exercise or when a patient is resting. This lower extremity leg pain is caused by decreased blood flow to areas of the leg which occurs due to a narrowing of the blood vessels. This narrowing is a result of atherosclerosis (build up of plaque and cholesterol) along the luminal walls of peripheral arteries, including the common iliac, external iliac, femoral and popliteal vessels.
In the study the iCAST™ Balloon Expandable Covered Stent is being used to re-open a narrowing in the diseased iliac artery. This landmark study, with Dr. John R. Laird as the primary investigator from UC Davis Vascular Center in Sacramento, CA, is designed to study 225 patients enrolled at 25 centers who present symptoms of iliac artery occlusive disease. The primary endpoint of this study is the incidence of target lesion revascularization (TLR) and restenosis (amount of re-narrowing of the treated blood vessel) at 9 months and 30-day death rates. The 100th patient was enrolled by Dr. Heron Rodriguez at Northwestern Hospital in Chicago, IL.
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