Abiomed Impella 2.5, Инструкция по эксплуатации

Страница: 135 / 211

6.27 Impella
®
System for Use During Cardiogenic Shock
Figure 6.25 Kaplan-Meier curve for 30-day survival using Classification B (patients with
Impella 5.0/LD)
Figure 6.26 Kaplan-Meier curve for 30-day survival using Classification B (patients with
Impella 2.5)
The Impella Registry data provides a real-world perspective on the use of the device in routine
practice in the proposed clinical setting for the Impella devices. Although some limitations exist
with respect to the interpretation of some of the data, the Impella Registry data showed the
following:
• Patients that require hemodynamic support in the setting of PCCS are sick and
present with a broad spectrum of pre-existing co-morbidities and risk factors
• The overall outcomes are favorable
• Despite the limited sample size, the data suggests that Impella 5.0 and Impella LD
patients do somewhat better than Impella 2.5 (in the proposed clinical setting)
In order to provide a benchmark for the Impella devices in a comparable clinical setting,
Abiomed analyzed the results from its real-world registry for the AB5000 Ventricle. The AB5000
Ventricle was PMA approved (P900023/S038) in 2003 as a temporary VAD for use to treat
PCCS. The AB5000 Registry was a retrospective registry, which included data collected from
U.S. sites between October 3, 2003 and December 11, 2007. The AB5000 Registry included IRB
approval and data for demographics, procedural and hemodynamic characteristics, outcomes
and adverse events.
6
C
LIN
IC
A
L E
X
P
E
RI
E
N
C
E