The U.S. Food and Drug Administration has authorized production of a simple, low-cost medical device designed at the University of Minnesota to mechanically inflate the lungs of patients suffering significant breathing problems for COVID-19.
The emergency-use device, called the Coventor, was designed in temporary working digs in a conference room at the U. It was conceived to sell for as little money as possible. And it would not exist without donations and collaboration involving private companies that don't normally work on the same team.
One of the most remarkable aspects of the Coventor is its timeline — in the space of 30 days (and nights), the device went from an early demo using an old toolbox as a component to an FDA-authorized device moving into professional production to potentially save scores of lives.
"30 days! It was 30 days from the toolbox to FDA authorization. That is incredible," said Arthur Erdman, director of the U's Earl E. Bakken Medical Devices Center.
The first unit will roll off a Boston Scientific assembly line in Maple Grove in another month or so. Randy Schiestl, vice president of research and development at Boston Scientific, said Wednesday that only 18 days passed between when the company got involved and when the FDA approved its joint authorization request with the U.
"We've looked at several devices. This is the one that we thought we could get to market the quickest," Schiestl said. The speed to market "demonstrates the collaboration of all parties under emergency-use authorization to move quickly and agilely."
Medtronic, the medical device company cofounded by Bakken in Minneapolis 71 years ago, also provided input on the product.
COVID-19 is a respiratory disease caused by a novel coronavirus discovered late last year in China. In severe cases, people with COVID-19 develop acute respiratory distress and can't breathe adequately because of fluid buildup in the lungs.
