FDA Clears Abiomed's Life Support System, Enabling Use in COVID-19 - COVID-19 Clinical Trial
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FDA Clears Abiomed’s Life Support System, Enabling Use in COVID-19

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.


Lockdowns Return as Europe Confronts Second Wave

Infections are rising sharply across Europe, including in the UK which on Wednesday announced 310 new deaths and 24,701 new cases. In England, a new study shows almost 100,000 people are catching the virus every day, putting pressure on the government to change policy from a regional approach. In France, Covid daily deaths are at the highest level since April. On Wednesday, 36,437 new cases and 244 deaths were confirmed. German health officials said on Thursday another 89 people had died in the past 24 hours, with a record 16,774 infections. “We are deep in the second wave,” European Commission President Ursula von der Leyen said. “I think that this year’s Christmas will be a different Christmas.”

Italy, Spain, France and the UK were among the worst-hit nations, with all imposing strict national lockdowns that over time brought cases, hospital admissions and deaths down to a very low level but ravaged economies.Restrictions started to lift in the early summer, with non-essential shops, bars and restaurants reopening, and travel restarting. But in August cases began to rise again, with a major acceleration in recent weeks that has alarmed policymakers.

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