FDA Sticks Newly Approved HeartWare VAD With Unexpected Labeling Requirement
This article was originally published in The Gray Sheet
HeartWare International Inc.’s HeartWare Ventricular Assist System has finally gained PMA approval, but FDA labeling requirements have sparked questions from analysts.
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HeartWare sold 134 HVAD ventricular assist systems in the U.S. following FDA approval in November and continues to rapidly add more centers to its customer base.
“Looking forward, we anticipate that the DT indication will continue to drive growth across the spectrum of centers, but with an increasingly important contribution from smaller transplant and open heart centers,” CEO Gerhard Burbach said.
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.