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# FDA Approves TransMedics Lung Transplantation System
- URL: https://www.fdaweb.com/fda-approves-transmedics-lung-transplantation-system/
- Published: 2018-04-12T12:00:00.000Z
- Updated: 2026-09-14T23:58:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141208

FDA has approved a TransMedics PMA for the Organ Care System Lung platform for use in standard double lung transplants. Approval was based on data from the INSPIRE Trial, the first and largest controlled clinical organ preservation trial in lung transplantation that was conducted at 21 leading international academic institutions, according to the company. The trial’s primary objective was to compare the safety and effectiveness of the device to current cold storage standard of care for preserving donor lungs.

The warm blood perfusion system is designed to allow a new type of organ transplant called a living organ transplant. It maintains organs in a warm, functioning state outside of the body to optimize their health and allow continuous clinical evaluation. The device increases the time that an organ can be maintained outside the body in a condition suitable for transplantation by reducing time-dependent ischemic injury.