FDA Grants 510(k) Clearance for Abiomed’s Innovative Cardiopulmonary Support Technology - Seite 2

“The clinical community has long been in need of innovation compared to traditional extracorporeal circulation therapy,” said Dr. Zachary Kon, 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.”

To help health care providers achieve the best possible outcomes, the Breethe system will be supported 24 hours a day, 7 days a week by Abiomed’s experienced field-based, in-hospital clinical team and on-call team from the Clinical Support Center.

This ECMO technology adds to Abiomed’s innovative portfolio focused on native heart and lung recovery. For many patients in cardiogenic shock, Abiomed now provides the treatment options of both the catheter-based Impella heart pump, which unloads the left ventricle, perfuses end organs and allows the heart to rest and recover, and Breethe, which provides oxygenation. Impella and Breethe can work together as ECpella to unload the heart and oxygenate the body.

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 centers 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. This benefit is not seen in patients treated with ECMO combined with the intra-aortic balloon pump (IABP). (see figure 1) Additionally, the study in the European Journal of Heart Failure found higher rates of heart recovery with ECpella use than with ECMO only (62% vs 36%; p=0.048).

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 edema or myocarditis.

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

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