Ethicon, part of the Johnson & Johnson Medical Devices Companies, has collaborated with Prisma Health to manufacture and distribute the VESper ventilator expansion splitter device.
VESper ventilator expansion device has been authorised for emergency use only during the COVID-19 pandemic.
Prisma Health has secured FDA EUA status for VESper ventilator expansion device
To address the drastic ventilator shortage during the COVID-19 pandemic, Prisma Health secured an emergency use authorisation (EUA) from the US Food and Drug Administration for the ventilator expansion device.
According to Prisma Health, the single ventilator will be fitted with the Ventilator Splitter to be used for two rescuable patients for ventilatory support during the current pandemic until individual ventilators are available.
Prisma Health president and CEO Mark O’Halla said: “We are pleased to announce this collaboration with Ethicon which brings nationwide scale and expertise for the manufacturing and distribution of VESper by a top-tier medical device company.”
Ethicon will apply the 3D printing manufacturing technology to produce and supply the VESper ventilator expansion splitter device without any cost to the healthcare providers in the US under the EUA during the current pandemic.
With an initial distribution limited to the US, the companies are preparing strategies to handle various regulatory pathways and fulfill orders related to the device across the world.
Prisma Health–Upstate department of medicine chair Dr Peter Tilkemeier said: “We are providing an option to the medical community, reviewed and authorized by the FDA. Each hospital and community needs to decide the best option for them as they begin experiencing ventilator shortages due to COVID-19.”
In May 2019, Ethicon agreed to acquire TachoSil Fibrin Sealant Patch from Takeda for $400m upfront in cash.
TachoSil is a ready-to-use surgical patch developed to help surgeons to achieve fast and reliable bleeding control and tissue sealing.
