FDA panel backs TransMedics’ lung transportation device

TransMedics, which seeks to replace ice-filled picnic coolers traditionally used to transport donor organs in the U.S., seems en route to an FDA nod for its OCS Lung device.

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.


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

Related: FierceMedicalDevices’ 2016 Fierce 15TransMedics

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.

Suggested Articles

What the NASH field needs, says Genfit CEO Pascal Prigent, is something like the Hb1Ac test for diabetes.

Dubbed “Project Nightingale,” the efforts were announced amid concerns and federal inquiries into the data’s safekeeping and patient consent for use.

Blocking a newly discovered molecule produced by B cells could slow their flow into the brain and offer a new way to treat MS, a Canadian team found.