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FDA Approves Transplant Lung Preservation System

Human lungs illustration

(NIH.gov)

29 Apr. 2019. The Food and Drug Administration approved a medical device that restores and maintains lungs for transplants that may not otherwise be acceptable. FDA announced its premarket approval on Friday, 26 April, of the Xvivo Perfusion System using an added Steen solution process.

The Xvivo Perfusion System is designed to keep donated lungs in suitable condition for transplants for patients with end-stage lung disease, the most severe form of lung diseases, such as chronic obstructive pulmonary disease (COPD), emphysema, and chronic bronchitis. Patients reach the end-stage of these diseases when the amount of air one can forcefully exhale in one second is less than 30 percent than normal, accompanied by low blood oxygen levels.

Lung transplants are often the only life-saving treatment available for people with end-stage lung disease, but many patients will die waiting for an available transplant. FDA cites data showing 2,530 lung transplants performed in the U.S. last year, but only 15 percent of lungs obtained from deceased donors are suitable for transplantation. Benjamin Fisher, director of FDA’s reproductive, gastro-renal, and urological devices division says in an agency statement, “Providing patients with access to safe medical devices that have the potential to be lifesaving remains a top FDA priority, and we support the development of innovative technologies that can increase the donor organ pool for transplant patients in need of suitable lungs.”

The Xvivo Perfusion System restores donated lungs considered of marginal quality to meet standards for transplantation. The system ventilates and irrigates donated lungs and enables the lungs to pump more oxygen, and maintains the lungs in that state and at normal body temperatures for up to 5 hours. The system includes a cart with electrical and mechanical equipment, which irrigate the lungs with a preservation solution. FDA’s approval also specifies Xvivo Perfusion’s Steen solution process for preservation, which extends stable lung functions for up to 10 hours.

The agency’s approval was based in part on results from a clinical trial in the U.S. of donated lungs that did not meet quality standards for transplants, which were restored and maintained with the Xvivo system, then transplanted in patients with end-stage lung disease. The results show 1-year survival rates of people with transplanted lungs treated by the Xvivo system is 86 percent, compared to 94 percent for recipients of donor lungs that meet transplant standards, a difference too small for statistical reliability.

FDA first cleared the Xvivo Perfusion System, made by Xvivo Perfusion AB in Gothenberg, Sweden, in 2014 under its humanitarian device exemption. However, that exemption limits a device’s number of uses to 8,000 per year. Under the new and more stringent Premarket Approval pathway, that restriction is now lifted. The company plans a post-approval study required by FDA to reveal long-term characteristics of donated lungs restored and maintained by the Xvivo Perfusion System, compared to lungs that originally met quality standards for transplants.

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