TransMedics, a medical technology company, has received an FDA PMA approval for expanded clinical indications of the Organ Care System (OCS) Lung.
TransMedics in involved in portable ex-vivo warm perfusion and assessment of donor organs for transplantation, to transform the organ transplant therapy for patients with end-stage lung, heart and liver failure.
The FDA approval is expected to enable the company’s OCS Lung System to be used in preservation and ex-vivo assessment of both standard criteria donor lungs.
In addition, the approval enables the usage of the system for the larger pool of donor lungs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation.
The approval is also expected to make the OCS Lung System to be used with both donors after brain death (DBD) and donors after circulatory death (DCD). Before being approved by the FDA, the OCS Lung System was approved for standard criteria lungs from DBD donors only.
OCS Lung EXPAND trial US principal investigators Dr. Gabriel Loor said: “Lung transplant surgeons now have access to a technology that enables preservation and assessment and use of lungs from a wide range of donors.
“Importantly, the OCS Lung System enables these capabilities from the minute the donor lungs are procured until they are ready to be transplanted into the recipient across wide distances.”
TransMedics is expected to expand its post-market Thoracic Organ Perfusion (TOP) Registry to collect long-term post-market data from recipients of all OCS Lung preserved standard criteria and initially deemed unacceptable donor lungs, based on the latest FDA PMA approval.
TransMedics CEO Dr. Waleed Hassanein said: “We are pleased with the FDA approval which uniquely positions the OCS Lung System as the only technology approved for both standard criteria and initially deemed unacceptable donor lungs for transplantation.
“With this approval, the OCS Lung System could enable a significant increase in donor lung utilization for transplantation in the US from those DBD and DCD donors that were initially deemed unacceptable based on limitations of cold storage.”
TransMedics said that the FDA approval is based on the results of the OCS Lung EXPAND pivotal international, multicentre trial that demonstrated safety and effectiveness of its OCS Lung System.
Hassanein added: “Now, these lungs can be preserved and assessed ex-vivo using our OCS Lung System to determine their suitability for transplantation. This marks a major milestone forward in our drive to expand access to life-saving transplant procedures for patients suffering from end-stage organ failure.”