2 results
Approved WMOCompleted
The primary objective is to evaluate the safety and efficacy of the PulseCath iVAC2L in highriskPCI patients who require left ventricular assistance. Safety will be assessed by theincidence of Cerebrovascular Accidents (CVA*s), thrombo-embolic…
Approved WMOCompleted
Establish the technical feasibility and safety of implantation of the investigational device, adjustment of the investigational device post-implantation and the ability of the investigational device to reduce mitral valve regurgitation.