Abiomed Impella 2.5, Instructions For Use Manual

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6.18 Instructions for Use & Clinical Reference Manual (US)
7. Evidence of any vascular disease that would have precluded placement of the device
(e.g., severely calcified vessel)
8.
Evidence of LV or RV thrombus
9. Documented presence of aortic insufficiency
10.
Aortic valve stenosis/calcification
11. Presence of mechanical aortic valve
12.
Obstructive, hypertrophic cardiomyopathy
13. Evidence of uncorrected Ventricular Septal Defect or Atrial Septal Defect (VSD/ASD) or
Patent Foramen Ovale (PFO)
14.
Mechanical manifestation of AMI (e.g., ventricular septal rupture, papillary muscle
rupture)
15. Any disorder causing fragility of blood cells or hemolysis
16.
Patient actively receiving CPR or any resuscitative maneuver for cardiac arrest
17. Sustained or non sustained VT/VF, unresponsive to treatment
18.
Other co-morbid condition(s) that could have limited the patient’s ability to participate
in the study or impact its scientific integrity
Patients were assessed at 30, 60, 180 and 1 year. During the assessments, clinical data was
obtained to assess the endpoints described below.
CLINICAL ENDPOINTS
Primary Endpoints
• Safety - Frequency of Major Adverse Events:
• Death
• Stroke
• Efficacy - Survival to:
• Recovery defined as 30-day survival post-explant or hospital discharge
(whichever is longer) with no other mechanical support or IABP OR
• Bridge-to-other-therapy defined as induction of anesthesia for surgery for
cardiac transplantation OR approved Ventricular Assist Device
Secondary Endpoints
• Safety
• Frequency of other Adverse Events (at 30, 60, 180, 365 days)
• Efficacy
• Improved Hemodynamics– Post-device implant improvements in
hemodynamics were to be demonstrated without additional adjunctive
inotropic or vasoactive medications versus baseline
• Device Placement and Technical Success
• Time-to-Recovery
• Reduction in Inotropic/Pressor Support