The FDA’s Gastroenterology-Urology Devices Panel voted favorably on TransMedics’ perfusion system for the transportation of lungs for transplant.
On Thursday, the panel voted 11-2 that the company’s OCS Lung system is safe, 8-5 that it is effective and 9-4 that the device’s benefits outweigh its risks, MassDevice reported. And while the FDA is not obligated to follow advisory panel recommendations, it typically does.
The OCS (Organ Care System) is CE-marked for the transportation of donor hearts and lungs and could become an alternative to cold, ischemic storage, which is standard in the U.S. It addresses the main issues with transporting organs under ice—the cold and lack of blood circulation can damage them, and they could even become unusable.
The OCS device includes a portable platform, a perfusion module, a sterile chamber that protects the organ and keeps it at the right temperature, and a solution set that delivers blood and nutrients to the organ.
The OCS Heart is currently in clinical testing in the U.S. In November 2015, the Gastroenterology-Urology panel called off a meeting surrounding a PMA submission for the device, saying it was no longer needed. And a few months later, it bagged a positive recommendation from the U.K.’s National Institute for Health and Care Excellence, which said the system was safe and effective enough for doctors to consider for their patients.
The Andover, Massachusetts-based company reeled in $51.2 million from the likes of the Fayerweather Fund, Flagship Ventures and Abrams Capital, in May last year. And in July, it added another $12.5 million to the haul.