Abiomed Impella 2.5, Instructions For Use Manual

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6.17 Impella
®
System for Use During Cardiogenic Shock
CARDIAC SHOCK AFTER OPEN HEART SURGERY
SUMMARY OF PRIMARY CLINICAL STUDIES
Clinical evidence was provided to support the overall safety and effectiveness of the Impella
devices to treat the indications for use provided above. Specifically, the results of the RECOVER I
study was provided as primary clinical evidence. RECOVER I was an FDA approved prospective,
single-arm study that evaluated the safety, hemodynamic benefit and feasibility for the Impella
5.0 and the Impella LD in a post-cardiotomy setting.
RECOVER I was a single armed study designed to evaluate the safety, hemodynamic potency
and outcomes of the Impella 5.0/LD in patients presenting with cardiogenic shock or low cardiac
output syndrome post weaning from cardiopulmonary bypass. Details of the study design are
below.
CLINICAL INCLUSION AND EXCLUSION CRITERIA
Inclusion Criteria
1.
Signed Informed Consent
2.
Age Eligible (18 ≤ Age ≤ 75)
3.
Body Surface Area (1.5 m 2 ≤ BSA ≤ 2.5 m 2 )
4.
Received stable infusion of one (1) high dose inotrope or two (2) medium dose
inotropes for a minimum (pre-set) time
5.
Cardiac Index (1.3 L/min/m 2 ≤ Cardiac Index ≤ 2.2 L/min/m 2 ) after the respective
minimum inotrope infusion time as indicated above
6.
Elevated Filling Pressures: 30 ≥ PCWP ≥ 20 mmHg OR 35 ≥ PA
7.
Diastolic ≥ 25 mmHg
8.
Time to enrollment within 48 hours of weaning from bypass
Exclusion Criteria
1.
Concomitant enrollment in another investigational device or drug trial that did not
complete the required follow-up
2.
BUN ≥ 100 mg/dL
3.
Renal dysfunction
4.
Hepatic dysfunction
5.
Presence of any .cardiac assist device (other than an IABP)
6.
Right ventricular failure
6
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