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'Coventor,' ventilator created at the U of M, gains FDA approval

The creative, makeshift ventilator concept born at the University of Minnesota can now move forward for manufacturing.

MINNEAPOLIS — Nine years ago, Stephen Richardson attended a medical school lecture at the University of Minnesota, where he listened to a professor discuss the implications of a future pandemic.

The professor, as Richardson recalls, predicted that a hypothetical public health crisis might overwhelm the hospital system and would surely result in a shortage of N95 masks and ventilators.

“It was always kind of swirling around in the back of my head,” Richardson said, “that the need could be there someday.”

So, when COVID-19 began to spread rapidly across the United States last month, Richardson – now a cardiac anesthesia fellow at the U of M – quickly formulated a plan to tackle the ventilator shortfall. He responded to the school’s request for emergency grant funding and worked with colleagues to develop a makeshift device that could keep patients breathing in the absence of any available ventilators.

The original prototype consisted of a toolbox, a wooden block, and other spare parts to mechanically pump an “Ambu bag,” which otherwise would need to be done manually through the hands of a first responder. Known as the “Coventor,” the device cannot replace regular ventilators but may provide an alternative method in especially dire scenarios, where critical patients would otherwise die without breathing assistance.

“Basically,” Richardson said, “a one-armed robot that provides a consistent breath for patients.”

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After working with Twin Cities-based MGC Diagnostics, the researchers took the Coventor to the Bakken Medical Devices Center at the U of M, where specialist Aaron Tucker and his own colleagues pumped out five new versions of the homemade ventilator.

“By that point,” Tucker said, “we had enough confidence that we could submit to the FDA for an Emergency Use Authorization.”

Late Tuesday evening, the public and private partners were thrilled to learn that the FDA granted that approval, paving the way for Boston Scientific to begin producing the Coventor for distribution (Medtronic has also assisted).

“Very big news,” Richardson said.

The FDA’s speedy decision will bring an unprecedented ventilator product to the market at a time of crisis – and the U of M will share details of the product to allow other manufacturers a chance to make the Coventor as well.

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The experts who helped create the device fully acknowledge that the Coventor should be reserved for the worst-case scenarios, say, if cases surge beyond the ventilator capacity in a certain state. Gov. Walz and other state officials have said their Stay at Home orders are intended to avoid this catastrophe and buy time for the procurement of critical supplies.

But the Coventor could be a useful stopgap – one that’s much easier to make, requires fewer parts, and comes at a fraction of the gost.

“And it fills that gap,” Richardson said, “while we build up the supply of traditional mechanical ventilators.”

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