Minnesota’s Coventor device made waves last month after researchers touted the design made from various parts totaling just $150. It’s now the first ventilator of its kind authorized for use under the FDA’s EUA for the COVID-19 pandemic.
A Boston Scientific spokesperson told MassDevice that the company will act as the sole manufacturer of the Coventor, having brought the concept through its product development process in just days.
Boston Scientific plans to begin with a limited run of products and scale up in accordance with demand as the coronavirus outbreak continues to develop. The company will sell the Coventors at cost — at approximately $1,000 per device.
“Our hope is that the Coventor will be useful in those clinical settings where traditional ventilators are not available,” University of Minnesota anesthesiologist Dr. Stephen Richardson said in a news release. “With FDA authorization, we are closer to that happening.”
The compact Coventor is the size of a desktop and does not require pressurized oxygen or air supply, unlike commercially available mechanical ventilators. With a frame and mechanical actuator designed to stabilize and compress a commercially available ambulatory ventilation bag connected to the patient’s endotracheal tube and external compressed oxygen, the device can also compress ambient air if oxygen is unavailable. That frame can be metal stamped, 3D printed or modified consumer goods, according to the Coventor website.
Financial and in-kind support for the initiative is being provided by Thief River Falls, Minn.–based Digi-Key, St. Paul, Minn.-based MGC Diagnostics, Protolabs and Teknic. The University of Minnesota itself and its Earl E. Bakken Medical Devices Center provided funding for the research.
FDA authorization allows for the design to move forward with production and distribution, with support from Boston Scientific and input from Medtronic as well. The Coventor’s specification will be made open source so other manufacturers can begin regulatory and production processes, too.
“This allows patients who wouldn’t otherwise have the opportunity to survive, to survive,” Richardson added. “The Coventor gives people a chance and that is what this is all about. Making the ventilator as fast as possible, pushing it to people everywhere.”
Other research teams could follow suit, as groups from Georgia Tech, Massachusetts Institute of Technology and others have come forward with similar alternative ventilator designs at low costs.
The FDA also approved Cleveland-based SecondBreath’s request to produce ventilators developed in Ohio and tested at a number of hospitals across the state.