FDA Grants Expanded Pediatric Indication for Orchid Safety Release Valve

Linear Health Sciences has received an expanded indication from the U.S. Food and Drug Administration (FDA) for the Orchid SRV, a tension-activated breakaway safety release valve that reduces the risk of IV catheter failure and replacement in hospitals. The expanded indication allows the Orchid SRV to be used in patients two weeks of age and older.
 
Ninety-five percent of more than 1,500 clinicians agree that IV dislodgements continue to pose significant safety risks for patients and hospitals, according to a study published in the Journal of the Association for Vascular Access. Reports have shown that up to 10% of the 342 million peripheral IVs annually¹ in the United States may dislodge,² costing more than $2 billion every year.³ Dislodgement is most frequently caused by patient confusion or catheter removal, loose dressing or tape, or tubing becoming tangled in bed linens.
 
“Vascular access, especially in pediatrics, is long overdue for positive disruption,” Linear Health sciences Co-Founder/CEO Dan Clark said. “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 the device prevented IV dislodgement by 91.1% 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 pounds) 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. 
 
Linear Health Sciences is a medical device company that has developed a proprietary, breakaway safety valve technology designed to improve the use of medical tubing in hospitals. The platform technology was developed to increase the safety and satisfaction of patients, caregivers, and healthcare facilities, while dramatically reducing costs. The company’s initial products include the Orchid SRV for use in IV catheter therapy and the Orchid SRV Type D device for use in surgical/wound, nephrostomy and abscess drainage. 

References
¹ iData research report
² “The Peripheral Intravenous Catheter Journey: A Prospective Cohort study of 1000 Patients.” Podium presentation by Nicole Marsh, RN, and Clair Rickard, RN, PhD, AVA 2017 annual meeting
³ Helm, et al. “Accepted but unacceptable: peripheral IV catheter failure” J Infus Nurs May-Jun 2015;38(3):189-203. doi: 10.1097NAN.0000000000000100