St. Jude Medical Announces FDA Approval of Assura™ Implantable Defibrillators with Features That Reduce Inappropriate Shocks

St. Jude Medical, Inc.

today announced U.S. Food and Drug Administration (FDA) approval of its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new implantable defibrillators feature SecureSense™ RV Lead Noise Discrimination, an algorithm that expands the St. Jude Medical ShockGuard® Technology and offers advanced sensing options designed to reduce the incidence of inappropriate shocks for patients with these devices. “The Assura product portfolio offers new features that protect patients from unnecessary defibrillation therapy,” said Mark A. Coppess, M.D., at The Stern Cardiovascular Foundation in Memphis, Tenn. “The SecureSense RV Lead Noise Discrimination algorithm is important because it provides a way to distinguish oversensing due to lead issues from real episodes that warrant life-saving treatment.”