TransMedica, based in Andover, Massachusetts, won FDA approval to introduce its Organ Care System (OCS) LUNG for use in standard double lung transplant procedures. The approval was based on the INSPIRE Trial, which the company touts as being the largest lung preservation for transplantation trial ever. Twenty one institutions around the world were involved comparing the OCS LUNG to existing cold storage systems, and the results showed that the new system is both safe and effective for preserving donor lungs within defined criteria.
OCS LUNG is a portable system that perfuses, ventilates, and monitors the lungs as they are transported from where they were harvested to where they will be implanted.
Though U.S. regulatory approval just came in, this system has already been available in Europe and Australia and almost 1,000 patients have already benefited from its use.
“The OCS platform is a paradigm-shifting technology developed to address the current clinical limitations in the transplant field. This PMA approval is the first crucial step forward towards dramatically improving clinical outcomes and expanding the number of life-saving organ transplant procedures in the U.S. and worldwide,” in a statement said Dr. Abbas Ardehali, Director of Heart and Lung transplantation at UCLA Medical Center and the U.S. Principal Investigator of the INSPIRE Trial. “I want to congratulate my co-investigators of the INSPIRE Trial and TransMedics for successfully completing this first of its kind trial in lung transplantation,” said Dr. Ardehali.
Product page: OCS LUNG…
Via: TransMedics…
