email article The TransMedics Organ Care System (OCS) Heart System got closer to regulatory approval as it emerged victorious from a contentious FDA advisory committee meeting. Members of the agency's Circulatory System Devices Panel voted 12-5 (with one abstention) that the OCS Heart System's benefits outweigh its risks as a device that could potentially widen the pool of donor hearts -- perhaps even reduce waitlist times -- by preserving non-standard donor hearts longer than traditional cold storage during transport. Panelists voting in favor did so despite complaining of flimsy safety and effectiveness data in the PROCEED II, EXPAND, and EXPAND CAP studies.