FDA Holds Up HeartWare LVAD Trial In Less Advanced Heart Failure Patients
This article was originally published in The Gray Sheet
Executive Summary
Investigators for the REVIVE-IT pilot study received a second deficiency letter from FDA May 11; researchers say they continue to work with the agency to move forward on the 100-patient, randomized trial.
You may also be interested in...
Thoratec Takes Over REVIVE-IT LVAD Trial From HeartWare
The pilot trial, cosponsored by NIH, will give ventricular assist devices a chance to prove their worth in heart failure patients not yet in the final stage of their illness.
FDA Panel Supports HeartWare VAD, Despite Trial Shortcomings
Benefits of HeartWare system, as well as the prospect of adding a competitive device to a market currently dominated by a single product, overshadow uncertainties from missing data, panelists vote.
HeartWare Points To Less Acute Patients As One Key To HVAD Success
As HeartWare awaits an approval decision for its first left ventricular assist device, the company says it is continuing to advance its pipeline and push forward with a longer-term strategy to maximize the treatable population for the product.