Food and Drug Administration approval to treat symptoms of patients with advanced heart failure who are not candidates for treatment with other devices such as cardiac resynchronization therapy, the agency announced on Friday.
Contract notice: successive supplies of single-chamber, dual-chamber pacemakers, pacemakers with resynchronization function and other devices for the needs of the department of hemodynamics of the multispecialty hospital ...
The FDA issued a safety communication to alert health care providers and patients about issues that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers to drain more quickly than expected without warning patients or health care providers.
Such patients typically have NYHA class III heart failure despite optimal medical therapy, but are not sick enough for a left ventricular assist device or heart transplant and do not qualify for cardiac resynchronization therapy (CRT).
Now, after a growing body of evidence suggests that older MRIs are safer than expected, Medicare is considering expanding coverage for MRIs in these patients, as well as in patients with cardiac resynchronization pacemakers or defibrillators.