AHA Journals, Author Interviews, Technology / 23.02.2017
Medtronic Pipeline Embolization Device Found Safe For Smaller Aneurysms
MedicalResearch.com Interview with:
Ricardo A Hanel, MD PhD
Endovascular and Skull Base Neurosurgery
Director, Baptist Neurological Institute
Endowed Chair, Stroke and Cerebrovascular Surgery
Jacksonville, FL
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Medtronic Pipeline Embolization Device has been approved for carotid artery aneurysms over 10mm in size, from the petrous to clinoid segment but given the efficacy of results on these larger lesions, it has been widely utilized for treatment of smaller lesions. PREMIER came from the need of assessing the results , safety and efficacy, of pipeline for use of aneurysms under 12mm, located on the carotid artery, all segments, and V3 segment of the vertebral artery.
PREMIER enrolled 141 patients treated at 22 centers (21 US, 1 Canada). Primary Safety effectiveness defined as total aneurysm occlusion, core lab adjudicated , at 1 year was 83.5%; with safety endpoint of major stroke/death at 30 days of 1.4% (2 patients), with 1-year major stroke and death rate of 2.1%.
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