Stopped: Production of the medical device was stopped
To ensure adequate seal of currently available stent grafts, a proximal 20 mm of healthy aorta is recommended. Extending the proximal landing zone into the arch by intentional covering of the left subclavian artery (LSA) without revascularization expose to serious neurologic complications. Serious risks are also known to accompany subclavian revascularization. The Valiant Mona LSA Thoracic Stent Graft System (Medtronic,Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency. The purpose of this study is to characterize the safety and effectiveness of this device for the treatment of Aneurysms and chronic Type B dissections of the arch.
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Safety events (aorta related mortality, stroke, paraplegia, left arm/hand ischemia)
Timeframe: 1 month
Effectiveness
Timeframe: 1 month