6 CLINICAL EXPERIENCE
PIVOTAL CLINICAL STUDY DESIGN – RECOVER RIGHT ........................ 6.1
Inclusion and Exclusion Criteria .......................................................................... 6.1
Study Organization …………………................................................................. 6.2
Statistical Considerations ……………................................................................ 6.3
ACCOUNTABILITY OF COHORT ……………................................................. 6.3
Study Population Demographics and Baseline Characteristics ..................... 6.4
Procedural, Support and Hemodynamic Characteristics ……....................... 6.5
Primary Endpoint Results …………................................................................... 6.7
Secondary Safety Endpoint Results …………................................................. 6.7
Secondary Effectiveness Endpoint Results ...................................................... 6.7
Other Relevant Clinical Findings ……..………................................................. 6.9
Trial Conclusions …………….…...................................................................... 6.10
