Brief Summary from the Circulatory System Devices Panel Meeting - June 8, 2004
A meeting of the Circulatory System Devices Panel was held on June 8, 2004. The Panel discussed, made recommendations, and voted on a premarket approval application supplement (P980012, Supplement 4) for the World Heart N100PC(q) Left Ventricular Assist System (LVAS).
The LVAS is intended for use as a short or long term bridge to transplantation in cardiac transplant candidates, and in patients with relative contraindication to transplantation who are expected to become transplant candidates with mechanical circulatory support, at risk of imminent death from nonreversible left ventricular failure. The LVAS is indicated for use both inside and outside of the hospital.
Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (10-1) that the application be found ‘not approvable’. The Panel cited concern with the lack of data to support the safety and effectiveness for the proposed expansion of the intended use for the device.
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Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site.