3 results
The purpose of this study is to document the efficacy, measured by allogeneic blood transfusion rate, of the Sangvia® Blood Management System when used for intra-operative, and if bleeding continues after surgery, possibly also postoperative…
Primary: To evaluate the safety of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.Secondary: To evaluate adverse events and study device performance.
The objectives of this are to establish the safety, tolerability, and preliminary efficacy of VRDN-001, and the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of VRDN-001 in NHV and TED patients over a dose range of 3.0 to 20.0 mg/kg.