FDA
25th March 2014

FDA Panel Supports HUD Exemption of XVIVO Perfusion System

Last Thursday, the Gastroenterology and Urology Devices Panel gave a unanimous recommendation for a Humanitarian Use Debice Exemption for a device made to improve the quality of donor lungs using warm perfusion after explant.

FDA Panel Supports HUD Exemption of XVIVO Perfusion System

Last Thursday, the Gastroenterology and Urology Devices Panel gave a unanimous recommendation for a Humanitarian Use Debice Exemption for a device made to improve the quality of donor lungs using warm perfusion after explant.

In three separate votes, the FDA panel voted 10-0 supporting the idea that the XVIVO XPS perfusion system is safe, and that it offers “probable benefit,” such that those benefits outweigh the potential risks of the device.

The XVIVO Perfusion system works by pumping warm STEEN, a nutrient solution, through lungs while monitoring lung functioning. This device was recommended for a humanitarian use device (HUD) exemption which is comparable to orphan status given to select drugs which are designed for patients with rare diseases.

If the XVIVO Perfusion system were to be approved under the HUD exemption, it would limit use of the device to facilities with a local institutional review board (IRB) as the IRB would need to supervise clinical testing of devices.

The FDA panel’s support for this device was mainly based on the results from two trials; HELP and NOVEL.

The HELP trial was carried out in Canada, and provided long-term data with 22 recipients of initially rejected lungs deemed acceptable after normothermic perfusion on a system similar in functionality to the XVIVO Perfusion system. An additional 39 recipients were included in the trial for a “compassionate extension phase.”

The results of HELP demonstrated improved gas exchange of the lungs and stable lung function by other parameters after being on warm perfusion. Similar results were observed with warm perfused lungs as in a control group that got standard cold-storage lungs. The 28 perfused-lung recipients for which there was data extending out to 3 years showed comparable survival to the control group.

The NOVEL trial was carried out in the United States, and showed similar 30-day survival compared with controls among patients who used the XVIVO Perfusion system after receiving 29 marginal-quality donor lungs transplants.

Nonetheless, NOVEL had limited data that only extended to 1 year, and it did not compare outcomes of patients who stayed on the waiting list for standard-criteria lungs.

In response to their review of NOVEL’s results, the FDA reviewers noted that, “Although limited and not statistically powered, the 9- and 12-month lung function data from the NOVEL study show trends of clinical detriment for the ex vivo lung perfusion lungs, compared to cold storage (control) lungs.” Additional concerns included the potential for clinicians to be misled with the device readouts of ex vivo lung function.

At this time, another ex vivo lung perfusion system is being evaluated in the ongoing INSPIRE trial.

The agency is not obligated by its panel’s recommendation, but it normally follows by it. 

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