Boston Scientific has shared that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) has unanimously recommended approval of an expanded indication for its cardiac resynchronisation therapy defibrillators (CRT-Ds), including the COGNIS CRT-D.
According to the company, the panel recommended the expansion to include the majority of the studied population of the landmark MADIT-CRT clinical trial, which evaluated the ability of these devices to slow the progression of heart failure in patients with asymptomatic or mild heart failure.
If an expanded indication is approved by the FDA, many additional heart failure patients would be eligible for this therapy, which has been clinically proved to slow the progression of this severe and life-limiting condition, stated Boston Scientific.
In response to a request from the FDA, Boston Scientific worked with the MADIT-CRT Executive Committee to perform an extensive subgroup analysis of the trial data.
Only few days before this development, Boston Scientific chose to stop shipment and decided to retrieve field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).
Boston Scientific determined that some manufacturing process changes were not submitted for approval to the FDA. The company says it has identified two instances of changes that, while successfully validated, were not submitted to the FDA.
Product families included in this advisory include: Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality.
