St. Jude resynch submission
This article was originally published in The Gray Sheet
Executive Summary
Final PMA module for cardiac reysnchronization therapy defibrillator line, including Epic HF ICD, Atlas HF ICD and Aescula 1055K and Quicksite 1056K left heart leads, are filed week of Dec. 15, according to St. Jude Medical. The clinical report from the RHYTHM (Resynchronization Hemodynamic Treatment for Heart Failure Management) ICD study is contained in the submission. Trial follow-up concluded the first week of December...