Magenta Medical Reports the Completion of Patient enrolment in Early Feasibility Study for Elevate Percutaneous Left Ventricular Assist Device
Shots:
- The patient enrolment has been completed in the US FDA-approved early feasibility study of Elevate percutaneous Left Ventricular Assist Device (pLVAD) for the high-risk percutaneous coronary intervention (HR-PCI) indication. The study enrolled 15 patients at Mount Sinai Hospital, St. Francis Hospital, and Heart Center, and North Shore University Hospital
- The device focuses to provide temporary mechanical circulatory support during HR-PCI procedures. The technology miniaturizes the powerful, percutaneous LVAD to fit an 8 Fr delivery system
- The device also received Breakthrough Device Designation from the US FDA for high-risk percutaneous coronary intervention and cardiogenic shock
Ref: PR Newswire | Image: Magenta
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