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.

Building on Abiomed’s existing portfolio of native heart and lung recovery products, the Breethe technology could aid in oxygenating patients experiencing cardiogenic shock or respiratory failure as a result of COVID-19, acute respiratory distress syndrome, severe acute respiratory syndrome and H1N1 influenza.

The FDA cleared the extracorporeal membrane oxygenation (ECMO) system to pump, oxygenate and remove carbon dioxide from blood in patients whose lungs can no longer adequately oxygenate the body’s vital organs. It is indicated during cardiopulmonary bypass for up to six hours.

When used in conjunction with Abiomed’s tiny, catheter-based Impella heart pump, a combination therapy known as Ecpella, the Breethe system can help increase cardiac output and patient survival in patients requiring left ventricular assistance. The ability to use the technologies in tandem could enable patients to walk during their recovery, which can aid in improving patient outcomes, as well as support COVID-19 patients during their recovery.

“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,” said Michael Minogue, Abiomed’s chairman, president and CEO. “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.”

Small footprint, mobility

The Breethe Oxy-1 system offers several advantages over traditional ECMO devices. These include a small physical footprint, the fact that it enables patient mobility and a simplified interface that does not require specialized training or a large team of providers to manage the patient.

The integrated pump lung unit is designed with volute spiral technology for consistent blood flow with minimal disruption and advanced gas exchange technology that reduces the amount of oxygen required to fully oxygenate patients.

Danvers, Mass.-based Abiomed acquired ECMO startup Breethe Inc. in April for an undisclosed sum. It had been an investor in the company since mid-2019.

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

The 510(k) nod from the FDA marks the Breethe system’s first regulatory clearance. Over the long term, the company looks to introduce the device in the European Union and Japan, Abiomed told BioWorld.

Evidence supports Ecpella therapy

More than 10,000 cardiogenic shock patients have been treated with Ecpella, and a number of clinical trials support its benefits. An analysis of data from 686 consecutive patients at 16 tertiary care centers in four countries, published earlier this month in Circulation, found that left ventricular unloading was associated with increased 30-day survival compared with controls (43% vs. 37%).

Additional studies in the European Journal of Heart Failure, ASAIO and the Journal of the American College of Cardiology have shown higher survival rates in patients receiving Ecpella therapy, compared with ECMO alone. Those results were not seen in patients treated with ECMO plus an intra-aortic balloon pump, the company said.

In August, the FDA granted emergency use authorization for the Impella heart pump to provide left ventricular unloading and support to COVID-19 patients undergoing ECMO therapy who develop pulmonary edema or myocarditis.

To ensure the best real-world outcomes with the Breethe system, Abiomed is promising 24-7 support by a field-based, in-hospital clinical team, as well as an on-call clinical support center.

The company reported $164.9 million in revenue for the first quarter of fiscal year 2021, ended June 30. Worldwide sales of Impella totaled $155.4 million, a 22% decrease from the same period in FY 2020 due to the impact of the COVID-19 pandemic.