Friday, July 30, 2021
TransMedics Group, Inc., a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its OCS™ Lung Solution for use in transplants using cold storage techniques. The solution, which is also cleared as a component of the company's OCS Lung System, is indicated for hypothermic flushing, storage and transportation of donor lungs for transplantation.
"This FDA clearance marks another achievement for TransMedics as we assemble the most comprehensive, market leading portfolio of organ preservation products to meet the clinical needs of the organ transplant market," said Dr. Waleed Hassanein, President and Chief Executive Officer. "With this new clinical indication, we are demonstrating our commitment to establishing TransMedics as the trusted partner to supply world-class organ preservation products to meet customer needs across all transplant indications as we execute on our mission to transform organ transplant therapy for the future."
The OCS Lung System is approved in the U.S. and the Company's OCS Heart System and OCS Liver System are currently under review by the FDA after receiving positive votes by the FDA's relevant advisory panels in April and July respectively.