The US Food and Drug Administration (FDA) has granted an expanded paediatric indication for Linear Health Sciences’ Orchid SRV tension-activated breakaway safety release valve.
Linear Health has developed the valve to lower the risk of IV catheter failure and replacement in hospitals.
The expanded approval now allows the use of Orchid SRV for patients aged two weeks and above.
Orchid SRV is a sterile, single-use connector designed for needle-free access. Once activated, it enables a quick and hygienic return to treatment, while enhancing the experience for both patients and clinicians.
In a clinical simulation test, which involved 360 Orchid SRVs, the device was found to avoid IV dislodgements by 91.1% in all test groups.
Orchid SRV is intended for use at the time of direct injection, intermittent infusion and continuous infusion.
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It is positioned between the current IV extension set and the general IV tubing connection for administering fluids to and from an IV catheter.
A sterile barrier is created when an IV line experiences tension of up to 3.25 lbs, causing the valve to separate and seal off both sides of the IV.
The clinician replaces the separated halves with a new, sterile valve for reinstating the line.
Linear Health co-founder and CEO Dan Clark said: “Vascular access, especially in paediatrics, is long overdue for positive disruption.
“Orchid SRV is already helping to change the standard of practice in vascular access and medical tubing applications in adult patient care and we expect it to do the same for paediatric patients, creating a 360° continuum of care across all patient populations receiving IV treatments.”