SJM Quadripolar Post Approval Study. This is an FDA mandated Study on our recently approved Quadripolar System: Unify Quadra CRT-D and the Quartet Lead.
The goal of this post approval study (PAS) is to characterize the chronic performance of the St. Jude Medical (SJM) Promote® Q/Promote® Quadra/Unify Quadra™ CRT-D system. The purpose of this PAS is to evaluate the acute and chronic performance of a Quadripolar CRT-D device system in a patient population indicated for cardiac resynchronization therapy.
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