6.7
Impella
®
System for Use During Cardiogenic Shock
SUMMARY OF SUPPLEMENTAL CLINICAL INFORMATION
Supplemental data from the Impella registry was provided to demonstrate real world use
for the patient population. Several analyses of the Impella Registry data were provided to
support the safety and effectiveness of use of the Impella devices. An analysis of the Impella
Registry was also provided to differentiate the outcomes for different treatment groups. In
addition, the sponsor also provided a benchmark comparison of the Impella Registry data to
a comparable registry dataset for its surgical VAD, the AB5000 Ventricle (PMA approved for a
similar indication). Clinical data from a separate clinical trial (RECOVER I) was also provided to
demonstrate hemodynamic effectiveness of the Impella 5.0/LD device during use. As further
evidence, a detailed literature review was also provided to support the overall safety and efficacy
of the Impella devices.
REAL-WORLD IMPELLA REGISTRY RESULTS (FOR ALL IMPELLA
DEVICES)
The Impella Registry is an ongoing, multi-center, retrospective, observational registry for
collection of de-identified data for patients treated with the Impella 2.5, Impella CP, Impella
5.0 and Impella LD Support Systems. The registry, which was started by Abiomed in 2009, is
open for participation by qualifying sites in the U.S. and Canada. Since the registry was started
to date a total 59 sites have participated. As of June 30, 2015, there were 40 open sites. The
sites include high and low volume centers, academic (teaching) and non-academic hospitals,
public and private institutions as well as for profit and not for profit centers, almost entirely from
the United States, thus providing a good representation of U.S. clinical practice. In addition,
Abiomed used the Impella Registry as supporting evidence in its original PMA (P140003)
application for the Impella 2.5 System. After reviewing the data, the FDA stated (In the PMA’s
SSED):
“Use of the device in a comparable patient group, as collected retrospectively via
Abiomed’s USpella (Impella Registry) database, showed results similar to those obtained in
the PROTECT II clinical trial for overall patient outcomes and hemodynamic support during
use.”
The data collection from the Impella Registry includes IRB approval, complete data monitoring,
adverse events (AEs) monitoring and CEC adjudication of major AEs. All data is entered
electronically by the sites. For this PMA, the time during which the Impella Registry data was
used is shown in Figure 6.5. Eligible patients were those who were reported in the Impella
Registry presented with AMICS and underwent mechanical revascularization with either
percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) and required
mechanical circulatory support with Impella devices.
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Summary of Contents for Impella 2.5
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