3 results
Approved WMOPending
The primary objective is to evaluate the safety and efficacy of the PulseCath during support of patients with impaired ventricular function, for a period between 24 hours minimum and 14 days maximum. Safety will be assessed by the incidence of…
Approved WMOCompleted
The objective of this study is to evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.
Approved WMOPending
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main…