Abiomed Impella 2.5, Instructions For Use Manual

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6.31 Impella
®
System for Use During Cardiogenic Shock
Figure 6.30 Decrease in inotropes and pressors (post-device placement) for RECOVER I
patients
Additional prospective clinical study data was provided to demonstrate a similar hemodynamic
effect for the Impella 2.5 device
.
LITERATURE REVIEW
The literature review provided has three different components. The first is a review and
characterization of the use of Impella in post-cardiotomy shock. The second is a review of the
BVS/AB5000 in the same patient population as this device has FDA approved for this indication.
The third is a review of ECMO in this population as ECMO, even though off-label, is used as an
alternate device to support these patients as well.
The Impella review encompasses a large body of scientific evidence with over 230 publications
totaling over 2537 patients for the use of Impella devices. Included in this Impella PCCS analysis
223 patients treated for the proposed indications for use. The literature review provides further
insight into the use of the Impella devices in routine clinical practice. The literature analysis
shows that post-surgical patients, who are deemed to require urgent hemodynamic support,
are in general old and present with high-risk features and co-morbidities, poor functional status
and greatly depressed cardiac function. The use of Impella devices to support these patients
generally appears to be safe and effective in these studies published in the literature. Also the
survival rates and morbidity profiles appear to be favorable for use of the Impella as compared
to surgical VADs.
Likewise, the review of ECMO in these same patients yielded a mean survival to either discharge
of 30 days at 33.9% (range 8% to 53%) representing 14 studies and over 1400 patients. ECMO
is a much more invasive system and more complex to use yielding a higher morbidity profile
than Impella. Overall, the literature analysis provides further reasonable assurance of safety and
effectiveness of the Impella devices in the proposed indications for use.
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