FDA Cancels TransMedics’ Donor Heart Care System Meeting

The FDA cancelled an advisory committee meeting scheduled last Wednesday to consider the premarket approval application for a TransMedics donor heart care system.

The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee was slated to discuss, make recommendations and vote on information regarding the TransMedics Organ Care System Heart. The system is intended to preserve a donor heart in a beating state from retrieval until transplantation.

FDA spokeswoman Deborah Kotz declined to elaborate on the reason for the cancellation, except to say that the agency determined that the meeting was no longer needed.

Company spokeswoman Marienne Sanders says TransMedics is communicating with the FDA, but she could not comment further.

The FDA also postponed an advisory committee meeting that was scheduled for last Thursday to discuss the classification of the product codes LKX and associated name “Device, Thermal, Hemorrhoids;” LRL and associated name “Cushion, Hemorrhoid;” and LKN and associated name “Separator, automated, blood cell and plasma, therapeutic.”

A future meeting date has not been set. — Jonathon Shacat