Abiomed Impella 2.5, Инструкция по эксплуатации

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6 CLINICAL EXPERIENCE
CARDIAC SHOCK AFTER ACUTE MYOCARDIAL INFARCTION ......................6.1
SUMMARY OF PRIMARY CLINICAL STUDIES ...............................................6.1
Prospective Randomized Trial: ISAR-SHOCK (For Impella 2.5) ........................... 6.1
Clinical Inclusion and Exclusion Criteria ............................................................ 6.1
Clinical Endpoints ............................................................................................6.2
Accountability of PMA Cohort .........................................................................6.2
Study Population Demographics and Baseline Parameters ................................6.3
Safety and Effectiveness Results ......................................................................6.4
Device Failures and Replacements....................................................................6.6
Financial Disclosure .........................................................................................6.6
SUMMARY OF SUPPLEMENTAL CLINICAL INFORMATION ...........................6.7
Real-World Impella Registry Results (For all Impella Devices) ............................6.7
Additional Analysis of the Impella Registry Data ............................................ 6.10
Benchmarking Impella vs. Approved VAD in AMICS ....................................... 6.12
Hemodynamic Effectiveness Results ............................................................... 6.14
Literature Review ........................................................................................... 6.16
CARDIAC SHOCK AFTER OPEN HEART SURGERY .......................................6.17
SUMMARY OF PRIMARY CLINICAL STUDIES .............................................6.17
Clinical Inclusion and Exclusion Criteria .......................................................... 6.17
Clinical Endpoints .......................................................................................... 6.18
Accountability of PMA Cohort ....................................................................... 6.19
Study Baseline Parameters ............................................................................. 6.19
Safety and Effectiveness Results ....................................................................6.21
Device Failures and Replacements..................................................................6.22
Financial Disclosure .......................................................................................6.22
SUMMARY OF SUPPLEMENTAL CLINICAL INFORMATION ........................ 6.23
Results ..........................................................................................................6.23
Hemodynamic Effectiveness Results ...............................................................6.30
Literature Review ...........................................................................................6.31