What’s Next?
An international pivotal trial is forthcoming to evaluate the safety and effectiveness of the JuxtaFlow RAD to sustain or enhance renal function in patients with renal insufficiency during and immediately following surgery with cardiopulmonary bypass. For additional information, please contact Elicia Dellinger at edellinger@rqmplus.com.
A completed single arm human feasibility study. Ten patients with renal impairment (eGFR 15-60) undergoing elective cardiac surgery with cardiopulmonary bypass were enrolled across three sites in Eastern Europe.
A completed double cross-over design human feasibility study. Seven patients presenting to the hospital with acute decompensated heart failure who did not adequately respond to high dose iv loop diuretics were enrolled in the US.
A porcine study of mock cardiac surgery using a parallel group design. Twelve animals underwent baseline, surgery and recovery comparing the JuxtaFlow RAD to no treatment.
A porcine study of a model of wet-warm heart failure using a parallel group design. Ten animals were randomized to the JuxtFlow RAD or no treatment.
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