Cardiology / Heart Transplantation

Donor Heart Preserver Survives Review by FDA Advisors
3 min read
fairly difficult
Panel had many bones to pick with the Transmedics OCS device
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.

"While the data is certainly not robust, it seems to me it is safe and effective, particularly given the choice of not using a heart, and hopefully the final decision will be that the chosen donors will be appropriate," said George Vetrovec, MD, of VCU Health Pauley Heart Center in Richmond, Virginia. He voted yes for OCS Heart's approval.

Voting no was Murray Kwon, MD, of UCLA School of Medicine, who said he did so "in the purest sense" based on the data submitted by TransMedics.

"I don't know if it's snake oil or if it's doing something. We don't have the proper controls," he said.

FDA staff…
Nicole Lou
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