FDA clears cardiopulmonary bypass support system for use in COVID-19, other conditions
Abiomed announced its compact cardiopulmonary bypass system received 510(k) clearance from the FDA.
During cardiopulmonary bypass, the compact new system (Breethe OXY-1, Abiomed) can help provide oxygenation in patients with cardiogenic shock or respiratory failure from causes such as acute respiratory distress syndrome, H1N1, SARS or COVID-19 for up to 6 hours, according to a press release from the company.
“The Breethe system is a breakthrough technology because it supports transition from bed to ambulation via system portability,” Zachary Kon, MD, associate professor of cardiothoracic surgery at the NYU Grossman School of Medicine, said in the release. “This system has the potential to revolutionize the way we think about extracorporeal life support therapy and can improve patient care.”
According to the release, in a study of 686 consecutive patients published in Circulation, use of the new system, in combination with Abiomed’s heart pump (Impella), was associated with increased 30-day survival (43% vs. 37%; P = .03).
Another the study published in the European Journal of Heart Failure found increased rates of heart recovery among patients who were treated using the combination system (Ecpella) compared with extracorporeal membrane oxygenation alone (62% vs. 36%; P = .048), according to the release.
Full commercial availability in the U.S. is expected in 2021, the company stated in the release.
“This ECMO technology will allow us to support new patient populations, such as COVID-19 patients and others who need lung support, and provide combination Ecpella therapy to Impella patients who need oxygenation,” Michael R. Minogue, chairman, president and CEO of Abiomed, said in the release. “Furthermore, we will advance the field of native lung recovery and improve patient outcomes by collecting critical research data and developing and teaching best practices.”