As the number of daily coronavirus cases in the U.S. once again begins to climb to new records, the FDA granted a 510(k) clearance to Abiomed’s compact, all-in-one life support system for bypassing a patient’s struggling heart and lungs.
The Breethe OXY-1 exchanges oxygen for carbon dioxide within the blood before pumping it back into the body, providing extracorporeal membrane oxygenation (ECMO) support for patients suffering from respiratory failure or cardiogenic shock caused by COVID-19 and other viruses, syndromes and conditions.
Abiomed snapped up the ECMO device earlier this year after it was submitted to the agency for review, following its April acquisition of Maryland-based Breethe and investments into the company’s development the year before.
The goal was to pair the system up with Abiomed’s miniaturized, catheter-based Impella heart pump to provide oxygenation therapy while also lessening the workload on the cardiac muscles in life-threatening cases. Dubbed ECPella by the company, the combined procedure has been performed at least 10,000 times over the past decade, according to Abiomed.
“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,” Abiomed Chairman, President and CEO Michael Minogue said in a statement, describing the Breethe system as a natural addition to the company’s product portfolio. The company is planning a limited initial release of the system, followed by a full U.S. commercial launch in 2021.
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“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,” Minogue added.
By incorporating an oxygen concentrator and removing potentially bulky hardware, the portable design of the OXY-1 system aims to support the movement of patients as they transition from the hospital bed to walking on their own. It has been cleared by the FDA for up to six hours of use, but it can be used for longer in emergency situations, under agency policies handed down during the COVID-19 pandemic.
Abiomed previously received an emergency use authorization for its Impella RP heart pump system for use in COVID-19 patients suffering from right-side heart failure, including those with clots blocking the flow of blood to the lungs.
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Separately, Abiomed also announced that its first patients have been treated with the smallest version of the company’s heart pump, the Impella ECP.
Described as the smallest heart pump in the world, it compresses down to a diameter of 3 millimeters for its trip through the blood vessels before being placed within the heart. The Impella ECP then expands to sit between the aorta and the left ventricle, across the aortic valve, and spins to help the heart pump blood at a rate of around 3.5 liters per minute.
The first two patients underwent the supportive procedure while receiving other high-risk interventions for severely narrowed coronary arteries. The investigational device is currently being evaluated through an early feasibility study.