User's Manual

US-ENGLISH – 15
5. ADVERSE EVENTS
Clinical data presented in this section are from the MSP clinical study.
PARADYM RF CRT-D is similar in design and clinical function to the
ALTO 2 MSP and OVATIO CRT-D devices. The data provided are
applicable to PARADYM RF CRT-D.
5.1. MSP STUDY
Sorin CRM conducted an international, multi-center, randomized clinical
trial of its cardiac resynchronization therapy system. Investigators
attempted to implant study devices in 190 patients. A total of 182 patients
received study devices and had an exposure of over 165 device years. Of
those patients, 19 received OVATIO CRT-D, 160 received ALTO 2 MSP,
and 3 received ALTO MSP. The clinical data collected on ALTO MSP,
ALTO 2 MSP and OVATIO CRT-D are applicable to PARADYM RF CRT-
D. The table below summarizes the adverse events observed for the
CRT-D system. No deaths were related to the system.