33
Table 21. Six Month Survival Post-Device Removal for FTW from CPB Pivotal Study (G030052/S21)
Device
Configuration
Number of Subjects
Primary Endpoint Success
Subjects Surviving to 6 Months
RVAD
3
1 (33%)
1 (33%)
RVAD with HM II
17
13 (76%)
13 (76%)
All Configurations
32
20 (63%)
17 (53%)
Clinical Study Safety and Effectiveness Conclusions
Four clinical studies have been conducted to evaluate the CentriMag system. Overall, ninety-five (95) patients were studied using
the device in a variety of configurations, including 15 as an LVAD only, 11 RVAD only, 23 BVAD and 46 as a hybrid system with
the CentriMag system supporting the right ventricle and another device supporting the left ventricle. The device was studied
treating cardiogenic shock following acute myocardial infarction or post-cardiotomy, failure to wean from cardiopulmonary bypass
and in patients with acute right ventricular failure from any cause.
In all studies, the adverse event rates were as expected for this gravely ill patient population. The number of adverse events judged
to be caused by the CentriMag system were relatively small. No unexpected adverse events were reported. There were no device
failures.
In all studies, patients exceeded the benchmark historical rate of 27% survival to 30 days post-support or hospital discharge,
whichever is longer, or to induction of anesthesia for the implantation of a long-term device or heart transplant, that was
established for the Pivotal Clinical Study.
The totality of the available data demonstrates that the CentriMag system is safe and effective for temporary short-term use for up
to 30 days.
25
CentriMag RVAD used in conjunction with HeartMate II LVAD (PMA P060040).