Wednesday, May 17, 2023
Medical device company Linear Health Sciences today announced it received an expanded indication from the U.S. Food & Drug Administration (FDA) for its Orchid SRV™, a tension-activated breakaway safety release valve designed to reduce the risk of IV catheter failure and replacement in hospitals. The expanded indication means that the Orchid SRV may now be used in patients two weeks of age and older.
According to a study published in J-AVA, 95 percent of 1,561 U.S. clinicians surveyed agreed that IV dislodgements continue to pose significant safety risks for patients and hospitals. In fact, reports have shown that, of the 342 million peripheral IVs in the U.S. each year1, up to 10 percent may dislodge2, costing more than $2 billion annually3. Dislodgement is most frequently caused by patient confusion or removal of the catheter, loose dressing or tape, or tubing becoming tangled in bed linens.
“Vascular access, especially in pediatrics, is long overdue for positive disruption,” said Dan Clark, co-founder and CEO of Linear Health Sciences. “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 pediatric patients, creating a 360-degree continuum of care across all patient populations receiving IV treatments.”
The Orchid SRV is a sterile, single-use connector for needle-free access that, when activated, makes return to treatment fast, simple, and clean, while improving both the patient and clinician experience. Clinical simulation testing of 360 Orchid SRVs showed that the device prevented IV dislodgement by 91.1 percent across all test groups. The Orchid SRV is indicated for use during direct injection, intermittent infusion, and continuous infusion.
Orchid SRV is placed between the existing IV extension set and general IV tubing connection intended to be used for delivery of fluids to and from an IV catheter. When tension (of up to 3.25 lbs.) acts on the IV line, the valve separates and seals off both sides of the IV, creating a sterile barrier. The clinician then restores the line simply by removing the separated halves and replacing them with a new, pre-packaged, sterile valve.
Linear Health Sciences won an Innovative Technology Award for Orchid SRV from Vizient, and the device will be offered to hospital customers through a non-exclusive contract with the group purchasing organization (GPO). Qualified clinical evaluations of Orchid SRV will continually quantify device utilization and drive Linear Health Science’s next generations of innovation.