Donor Heart Preserver Survives Review by FDA Advisors
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 s...
Source: medpagetoday.com