St. Jude To Acquire CardioMEMS As FDA Approves Heart Failure Monitor
This article was originally published in The Gray Sheet
Executive Summary
FDA approved the CardioMEMS HF wireless heart-failure monitor, and St. Jude has exercised its option to buy the technology and its manufacturer. The approval is based on the results of the CHAMPION pivotal trial, which showed that patients monitored with the remote, implantable system needed fewer hospitalizations.
You may also be interested in...
CardioMEMS Heart Failure Monitor Shows Mortality, Hospitalization Benefit
A retrospective analysis presented at the American College of Cardiology meeting in San Diego shows that pulmonary artery pressure monitoring with St. Jude’s CardioMEMS reduced hospitalization and mortality in patients with heart failure and reduced ejection fraction.
Medicare Add-On Payments Granted For Cardiac, Neuro Devices
CMS agreed to grant new tech add-on payments to St. Jude’s CardioMEMS implantable heart failure monitoring system and Abbott’s MitraClip mitral valve repair system, but it took some convincing. The agency also granted an add-on for NeuroPace’s RNS responsive neurostimulator system to treat seizures.
PMA Data: High Approval Volume, Reduced Supplement Review Time For May
FDA achieved highs in the volume of original PMAs and supplements approved in May, and lows in PMA supplement review times for approvals that month, according to analysis by “The Gray Sheet” of the agency’s most recent official monthly PMA listing. Exclusive graphical elements included.