UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an Oxford-based medical device company Penlon’s Prima ES02 model ventilator for use in hospitals.
The firm has developed the new ventilator model by working in collaboration with the VentilatorChallengeUK consortium. Several industry partners including High Value Manufacturing Catapult, Ford, a number of UK based F1 teams and Siemens are part of the consortium.
VentilatorChallengeUK consortium chair Dick Elsy said: “The consortium had undergone stringent testing and clinical trials for the last two weeks.
“Ventilators of this type are complex and critical pieces of medical equipment, so ensuring the absolute adherence to regulatory standards and meeting clinical needs were always our priorities.”
The device is said to be the first newly-adapted ventilator design from the government’s Ventilator Challenge, and is ready to be sent to the NHS frontline to support coronavirus patients.
Prima ES02 device is a newly-adapted ventilator design
With design adapted from existing models, Prima ES02 device meets the rapidly manufactured ventilator system specification.
The fully intubated mechanical ventilator has been designed to support the critically ill patients with a range of functions including volume and pressure controlled ventilation.
The UK Government has placed an order for 15,000 devices.
The UK Prime Minister has urged British manufacturing firms to speed-up the supply of ventilators, to save lives during this coronavirus pandemic.
In addition, the government has partnered with several technology and engineering firms and smaller manufacturers, to quickly build existing, modified or newly designed ventilators.
Duchy of Lancaster Chancellor Michael Gove said: “The approval of Penlon’s device underlines the significant progress being made in the Ventilator Challenge.
“I pay tribute to the incredible ingenuity and commitment of our manufacturing industry, coming together as part of the national effort to protect the NHS and save lives.”
