CorVent Medical’s RESPOND-19 Ventilator Receives FDA Emergency Use Authorization for Multiple Patient Use

CorVent Medical (New York, NY, USA) has been issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for primary critical care use of the company's RESPOND-19 Ventilator.

Establishing a new category of ventilators, RESPOND-19 is designed for rapid expansion of critical care ventilation capacity to allow hospitals to treat more patients suffering from acute respiratory distress syndrome (ARDS) during times of greatest need. The CorVent RESPOND-19 Ventilator complements existing ventilator capacity by providing primary critical care support for multiple patient use in a cost-efficient device. The intuitive system combines sophisticated ventilation features with a plug-and-play setup to streamline patient care management.

In addition, the system's multi-stage antiviral filters provide excellent infection control to protect both patients and healthcare providers. Optimized for long-term storage with no maintenance, the reliable system eliminates the need for costly service contracts required for ICU ventilator systems. COVID-19 has transformed the market and RESPOND-19 aims to address the immediate and growing need for flexible, critical care ventilator capacity. With EUA granted, the RESPOND-19 Ventilator is now available for commercial use in the US and the company is expecting CE Mark in early 2021.

"When demand exceeds ventilator supply, healthcare providers need the ability to quickly scale resources in a safe and financially responsible manner," said Dr. Patrick Troy, pulmonologist at Hartford Hospital in Hartford, CT and Chief Medical Officer of CorVent Medical. "Moving forward, successful healthcare disaster preparation will inevitably include reliable surge support ventilators that can be deployed on-demand to meet an increased patient demand."

"Current critical care ventilators are not designed for periodic use, such as during global pandemics or disaster recovery. They require costly maintenance and additional time to deploy from long-term storage and are not optimized to prevent the transmission of respiratory illnesses," commented Richard S. Walsh, CEO of CorVent Medical. "Our team's expertise in ventilator development and proven track record of bringing innovative products to market positions us to successfully address this pressing clinical need. We are proud that the RESPOND-19 ventilator expands access to lifesaving respiratory support, in a financially sustainable way, for hospitals and government agencies during this healthcare crisis and beyond."

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