In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests.
In March 2018, FDA approved the OCS™ Lung System (via the pre-market approval (PMA) application, P160013), which is described as “a portable organ perfusion, ventilation, and monitoring medical device indicated for the preservation of standard criteria donor lungs”. While the initial PMA only approved the device for use with donor lungs in relatively pristine condition, TransMedics submitted a supplement that expanded the device’s indication for use. In this recent supplement, donor lung pairs initially deemed unacceptable for procurement and transplantation due to the limitations of cold storage could now be used.
When it comes to donor lungs, an estimated eight out of ten pairs go unused. Donor lungs generally need to be the appropriate size, age, and blood type to be transplanted successfully, and they also need to be healthy and functioning well. Assessment of a donor lung’s condition can be difficult, and the traditional method of storing and transporting donor lungs in chests of ice limits the distance those organs can be transported and remain viable for transplantation. Donated organs in cold storage are only viable for a limited amount of time, as being cut off from a blood supply for any extended amount of time, not to mention exposure to the cold, can result in permanent damage. Additionally, organs removed from the donor and placed in cold storage for transport cannot readily be assessed, as they are neither functional nor metabolically active.
The TransMedics website describes the OCS Lung System, “as a miniature intensive care unit that keeps organs alive and healthy by maintaining them in a natural state that mimics the human body”. The OCS Lung System includes an enclosure with both mechanical and electrical components that are used to warm, ventilate, and supply the lungs with oxygenated and nutrient-enriched blood. The aim of the device is to increase the distance a donated lung can travel (expanding the number of potential patients that a lung could help), optimize the health of the donated lung during transport, as well as provide physicians time to monitor and assess the viability of the organ outside the donor’s body.
In addition to their OCS™ Lung System, TransMedics is investigating the potential use of their OCS technology to support both heart and liver transplants. To date, the OCS Heart and OCS Liver devices are limited by federal law to investigational use only. In the US, both devices have been given Investigational Device Exemption (IDE) approval by FDA, allowing them to be used in clinical studies to collect the safety and effectiveness data required to support their future PMA applications.
We at AcKnowledge RS are excited about medical devices and technological advances big and small, and the support and hope being provided to patients with advanced lung, heart, and/or liver disease is very exciting indeed!