Eurosets Srl reported the first patient treatments using Colibri, which the company asserts is the world’s lightest extracorporeal life support (ECLS) system. This first clinical procedure was performed using an ECLS device weighing less than 9 kg in the ICU department at the Arnaud de Villeneuve University Hospital in Montpellier, France.
Chinabridge (Shenzhen) Medical Technology Co. Ltd.’s extracorporeal membrane oxygenation (ECMO) machine Lifemotion gained NMPA approval, making it the first domestically developed ECMO unit given a greenlight in China. The approval includes the ECMO machine and the disposable consumables used in combination to treat acute respiratory failure or acute cardiopulmonary failure in seriously ill COVID-19 patients.
Abiomed Inc. has won the U.S. FDA’s nod for its Breethe Oxy-1 device, an all-in-one, compact cardiopulmonary bypass system designed for easy mobility. The company plans a controlled release at U.S. hospitals between now and March of 2021, with widespread availability later that year.
The restrictions on elective surgeries as hospitals struggle to manage the unfolding global pandemic are hitting medical device companies particularly hard. Abiomed Inc., which specializes in a tiny, minimally invasive heart pump to support heart failure patients, saw its first fiscal fourth-quarter revenue flatten as procedures were postponed. Still, U.S. revenue remained stronger than Wall Street had expected, even as ex-U.S. revenue had deeper declines.
The U.S. FDA has given its nod to Novalung, a heart and lung support system from Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure. The Waltham, Mass.-based company noted that Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use.
