Medovate – a pioneering medical device development company – has today announced it has successfully secured additional CE Mark Regulatory Approvals for its game-changing SAFIRA® (SAFer Injection for Regional Anaesthesia) technology to include an NRFit™ syringe and a Palm Operator.
Within the last year alone, Medovate has achieved CE Mark Regulatory Approval covering five devices in its SAFIRA range: infusion driver, foot pedal, luer syringe, NRFit™ syringe and palm operator. These latest product range additions are intended to further improve patient safety and offer greater control to anaesthetists.
The NRFit™ syringe provides a second option to the universal Luer connection syringes with which the system was originally introduced. It is recognised that Luer connectors carry the potential for medical tubing misconnections, which can lead to incidences of wrong route administration of medicines and gases. The NHS issued a Patient Safety Alert in 2019 to recommend and support the safe transition from the Luer connector to NRFit™ for the delivery of regional anaesthesia.
With the provision of a brand-new Palm Operator, Medovate hopes to offer anaesthetists more versatility and choice. The palm operator uses the same colour coding as the original foot pedal operator, which remains a key part of the product range for the infusion and aspiration of anaesthetics. The palm operator is ergonomically designed to comfortably fit under a surgical glove, within the palm of a hand. The addition of a hand operator product to the SAFIRA® range offers regional anaesthetists greater choice when using SAFIRA®.
Alan Finnerty, Technology Director of Medovate said: “Medovate is dedicated to improving patient care. The extension of our CE certification to include these new devices is a significant milestone for the company, and testimony to the focus and commitment of the team. It also consolidates our unique offering to patients and anaesthetists across the globe, with safety remaining a top priority.”
Stuart Thomson, Managing Director at Medovate commented “Medovate is very proud to launch these next devices in our SAFIRA® product range. We are now able to support healthcare providers with a complete solution to their regional anaesthesia needs with both hand and foot operators, and a SAFIRA® syringe - whatever the stage in their transition from Luer to NRFit™ devices.”
Developed with the NHS to promote safer injection during peripheral nerve block procedures, SAFIRA® transforms regional anaesthesia into a one-person procedure, giving the anaesthetist full control of the injection at all times.
It also includes a built-in safety mechanism to limit injection pressure helping to reduce the risk of nerve damage and promote patient safety. Regional anaesthesia is used to provide pain relief during and for the hours after an operation. It involves anaesthetising a specific region of the body with local anaesthetic, normally under ultrasound guidance.
Over 20 million regional anaesthetic nerve blocks are performed each year throughout the EU and US (1). As the use of regional anaesthesia continues to grow globally the option of using an NRFit™ syringe, together with either a foot or hand palm operator, with SAFIRA® for regional anaesthesia procedures has the potential to make a significant impact on improving patient safety.
This year SAFIRA® has been showcased at leading events for regional anaesthesia, including the European Society of Regional Anaesthesia & Pain Therapy (ESRA) where it was the subject of a dedicated symposium on mitigating to avoid the risks of nerve damage. The game-changing technology has also recently been exhibited at the RA-UK Annual Scientific Meeting 2021 in Sheffield, and at the American Society of Regional Anesthesia and Pain Medicine (ASRA) 46th Spring Meeting in Orlando, Florida.
SAFIRA® has been launched in the United States, Australia and New Zealand and will soon be available in the UK and across Europe by Medovate's distributor partner Vygon with both syringe options, Luer and new NRFit™.
Further regulatory approvals for the palm operator are expected throughout 2021 which will enable the full SAFIRA® product range to be made available in the United States and additional key markets as further distributors are appointed.
Discover more about SAFIRA® here
(1.) Fong-Soe-Khioe R. Health Economic report Medovate commissioned written by a health economist from the University of East Anglia (UEA)