Kaplan-Meier Survival: HeartMate II
Bridge-to-Transplantation Post-Approval Study

After FDA approval of the HeartMate II for BTT in 2008, the first post-approval study utilizing the national Interagency Registry for Mechanically Assisted
Circulatory Support (INTERMACS) was initiated to
assess outcomes with the HeartMate II in a broader
patient care environment.

• The HeartMate II BTT Post-Approval Study included 338 patients (169 HeartMate II) across 77 institutions
• 62% were INTERMACS profile 1 (critical cardiogenic shock) or
  profile 2 (progressive decline on inotropes), representing the sickest
  heart failure patients
• The study demonstrated superior survival for HeartMate II patients—90% survival at 6 months versus 79% for the comparator group, and 85% survival at 12 months versus 71% for the comparator group
• Additionally, the HeartMate II BTT Post-Approval Study illustrated a lower rate of adverse events and a marked improvement in quality of life over
  the course of follow-up as measured by the EuroQol instrument, with
  scores doubling

HeartMate II Left Ventricular Assist System Instructions for use #105747. Pleasanton, Calif: Thoratec Corp; Oct 2010.