Abbott has announced the initiation of MOBILITY, a clinical trial studying the safety and efficacy of the Absolute Pro peripheral self-expanding stent system in patients with iliac artery disease.
Abbott has announced the initiation of MOBILITY, a clinical trial studying the safety and efficacy of the Absolute Pro peripheral self-expanding stent system in patients with iliac artery disease.
“Iliac artery occlusive disease has the potential not only to have a significant impact on a patient’s ability to carry on daily activities, but it also can be an early sign of plaque buildup in other parts of the body,” said Manish Mehta, director of Endovascular Services, The Vascular Institute for Health and Disease, Albany Medical Center, USA, and co-principal investigator of the MOBILITY trial.
“The lower extremity discomfort and fatigue with walking and exercise caused by this debilitating disease can tremendously impact a patient’s overall quality of life, making it critical to find effective treatments. Data from the MOBILITY trial will be an important addition to iliac stenting research.”
“As medical technology has advanced, iliac stenting has become an excellent first-line interventional treatment option for patients, as it is less invasive than surgery and has the potential to improve patient outcomes,” said Tony Das, director, Peripheral Vascular Interventions, Cardiology Section, Presbyterian Heart Institute in Dallas, USA, and co-principal investigator of the MOBILITY trial.
“The MOBILITY trial will provide understanding into how the Absolute Pro peripheral stent treats the narrowing in the iliac artery to improve blood flow to the leg, with the ultimate goal of alleviating pain associated with peripheral arterial disease and improving the patient’s ability to walk and exercise.”
The MOBILITY trial is designed to study 150 patients at up to 50 centres in the United States.
The primary endpoint is a composite measure of major adverse events at nine months. A major adverse event is defined as death due to any cause, heart attack (myocardial infarction), clinically driven target lesion revascularization, and limb loss (amputation only) on the treated side.
“The MOBILITY trial will provide valuable evidence about the performance of the Absolute Pro peripheral stent, and it will be used as the basis for a peripheral vascular indication filing for the device,” said Charles Simonton, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular.
“Abbott is a company with a broad-based vascular business, and the start of the MOBILITY trial is another example of the company’s commitment to researching and developing advanced products in both the endovascular and coronary areas to improve patients’ overall vascular care.”
