Heartware International Inc. (HTWR) said it has submitted a Pre-Market Approval or PMA application to the U.S. Food and Drug Administration for the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.
The PMA submission includes data from HeartWare's pivotal ADVANCE clinical trial, an FDA approved IDE study designed to evaluate the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure, HeartWare added.
Earlier announced results for ADVANCE showed that 92% of the investigational device patients met the per protocol primary endpoint of the trial, which was defined as alive on the originally implanted device, transplanted or explanted for recovery at 180 days. Further, ADVANCE demonstrated that 94% of the investigational device patients enrolled in the study achieved a survival endpoint at 180 days.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.