{"id":976380,"date":"2026-06-29T06:33:53","date_gmt":"2026-06-29T10:33:53","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/united-therapeutics-corporation-announces-fda-approval-of-the-lungfx-device-for-centralized-ex-vivo-lung-perfusion\/"},"modified":"2026-06-29T06:33:53","modified_gmt":"2026-06-29T10:33:53","slug":"united-therapeutics-corporation-announces-fda-approval-of-the-lungfx-device-for-centralized-ex-vivo-lung-perfusion","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/united-therapeutics-corporation-announces-fda-approval-of-the-lungfx-device-for-centralized-ex-vivo-lung-perfusion\/","title":{"rendered":"United Therapeutics Corporation Announces FDA Approval of the LungFX\u2122 Device for Centralized Ex Vivo Lung Perfusion"},"content":{"rendered":"

<\/p>\n

United Therapeutics Corporation Announces FDA Approval of the LungFX\u2122 Device for Centralized Ex Vivo Lung Perfusion<\/b><\/p>\n

LungFX\u2122 is the first device approved for centralized ex vivo lung perfusion for donor organs not otherwise used for transplant, an important step in advancing United Therapeutics\u2019 platforms<\/i><\/p>\n

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE<\/a>)–
\nUnited Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA<\/b>) has granted premarket approval (PMA<\/b>) of the LungFXTM<\/sup> device (LungFX<\/b>) for use in centralized ex vivo lung perfusion (EVLP<\/b>), a procedure that enables donor lungs to be assessed outside the body after procurement and before transplantation.<\/p>\n

\nThe PMA, submitted by United Therapeutics\u2019 wholly owned subsidiary, Lung Bioengineering Inc., included comprehensive safety and effectiveness data supporting use of LungFX to perform EVLP in a centralized facility.<\/p>\n

\nLungFX is indicated for centralized, ex vivo (outside the body) evaluation of deceased-donor lungs (single and double) that cannot be placed for transplantation by an organ procurement organization (OPO<\/b>) with any of the matched candidates if using direct-to-recipient procurement and preservation procedures. LungFX provides normothermic perfusion and ventilation of procured donor lungs initially stored with cold static preservation solution.<\/p>\n

\nLungFX is intended to allow for re-assessment, in a controlled environment, of the suitability of procured donor lungs for transplantation into male and female patients aged 18 years or older with end-stage lung disease awaiting first-time (double or single) lung transplantation. Lungs accepted for transplantation after LungFX require a second period of storage with cold static preservation solution, and cumulative preservation time of transplanted lungs is not intended to exceed 20 hours.<\/p>\n

\nTo date, Lung Bioengineering has performed 1,100 EVLP procedures using other approved devices, with 600 lungs accepted for transplant. Lung Bioengineering expects to add LungFX to its available services in 2027.<\/p>\n

\n\u201cToday\u2019s approval is a big step forward in reducing the large number of donor lungs \u2014 over 80% \u2014 that are unfortunately left behind instead of being transplanted,\u201d said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. \u201cThe FDA approval of our LungFX device also marks an important milestone on our path toward using advanced technologies to create an unlimited supply of transplantable organs.\u201d<\/p>\n

\n\u201cToo many donor lungs go unused today,\u201d said Dr. Kenneth McCurry, M.D., Director of the Cleveland Clinic Enterprise Transplant Center and investigator in the LungFX pivotal trial. \u201cEVLP with this device provides additional clinical data to transplant teams to help determine whether donated lungs that might otherwise go unused are suitable for transplant. Our work with Lung Bioengineering over the last ten years has significantly increased the number of patients we have been able to successfully transplant.\u201d<\/p>\n

\n\u201cLungFX is the first EVLP device approved specifically for use in a fit-for-purpose centralized facility, expanding access for transplant programs without requiring them to build EVLP capabilities within their own hospitals. It also strengthens United Therapeutics\u2019 platform for advancing new technologies designed to enhance donor lung function,\u201d said Brandi Zofkie, M.P.H., Associate Vice President of Lung Bioengineering.<\/p>\n

Lung Bioengineering Inc.<\/a>, a wholly owned subsidiary of United Therapeutics, is the global leader in centralized EVLP. The company owns and operates facilities in Silver Spring, Maryland, and Jacksonville, Florida, dedicated to performing centralized EVLP procedures designed to extend preservation and enable assessment of donor lungs that might otherwise be deemed unsuitable for transplant.<\/p>\n

IMPORTANT SAFETY INFORMATION<\/b><\/p>\n

CONTRAINDICATIONS<\/b><\/p>\n

\nThere are no known contraindications.<\/p>\n

WARNINGS AND PRECAUTIONS<\/b><\/p>\n