US FDA approval for Abiomed’s Breethe OXY-1 system

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Breethe

The US Food and Drug Administration (FDA) has granted Abiomed a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 system. Used in conjunction with Abiomed’s Impella heart pump, the system can unload the heart and oxygenate the body, a combination therapy known as ECpella.

The ECMO system provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation. The 510(k) clearance is to pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass for up to six hours.

Abiomed’s Breethe technology is a novel, easy-to-use cardiopulmonary bypass system that is designed for mobility. The components of the system are designed to reduce the overall equipment footprint, support patient ambulation, and provide an intuitive interface for health care providers to setup and manage.

“As a leader in technology and innovation, the Breethe system is a natural addition to Abiomed’s existing product portfolio,” said Michael R Minogue, Abiomed’s chairman, president and chief executive officer. “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. 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.”

“The clinical community has long been in need of innovation compared to traditional extracorporeal circulation therapy,” said Zachary Kon, cardiothoracic surgeon at New York University, New York, USA. “The Breethe system is a breakthrough technology because it supports transition from bed to ambulation via system portability. This system has the potential to revolutionise the way we think about extracorporeal life support therapy and can improve patient care.”

Multiple studies support the association of ECpella therapy to improve outcomes for patients who are suffering from cardiogenic shock and require oxygenation. A study published this month in Circulation examined data from 686 consecutive patients at 16 tertiary-care centres from four countries and found ECpella was associated with increased 30-day survival (43% vs 37%; p=0.03). The European Journal of Heart Failure, ASAIO, and the Journal of the American College of Cardiology have published studies that conclude use of ECpella was associated with increased survival rates, as compared to patients who were treated with ECMO only.

In August, the FDA issued an emergency use authorization (EUA) for all left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary oedema or myocarditis.

Abiomed plans to have a controlled launch of the Breethe system at hospitals in the USA, with full US commercial availability expected in calendar year 2021.


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