Wednesday, October 7, 2015

TransMedics wins FDA panel date for organ preservation device

Mass Device | Brad Perriello

TransMedicsThe FDA plans to convene an advisory panel to review the pre-market approval bid for the organ preservation device made by TransMedics.

The FDA’s Gastroenterology & Urology Devices panel is slated to meet Nov. 18 to discuss Andover, Mass.-based TransMedics’ PMA bid for its Organ Care System, which is designed to perfuse a donor heart with warm, oxygenated blood and monitor its status until transplantation.

TransMedics is seeking an indication for “a portable, ex vivo organ perfusion system intended to preserve a donor heart in a near-normothermic and beating state from retrieval until the eventual transplantation into a suitable recipient,” the federal safety watchdog said. Although it’s not bound by advisory panel recommendations, the FDA often follows their lead in its decisions.

In July, The Lancet published results from the Proceed II study of 130 heart transplant patients, who were randomized to receiving hearts preserved with the OCS or via cold static storage. The TransMedics device came up non-inferior for the trial’s primary endpoint of 30 day patient and graft survival compared with traditional cold storage (94% vs. 97%). Continue reading.


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