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™ safety release valve. The expanded indication means that the Orchid SRV may now be used with all IV access methods.
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. It is now indicated for use with central venous catheters, peripherally inserted central catheters (PICCs), peripheral IV catheters, and intraosseous cannulation, during direct injection, intermittent infusion, and continuous infusion, in patients two weeks of age and older.
“Maintaining vascular access is one of the most fundamental, yet most over-looked, treatment modalities in medicine today,” said Dr. Ryan Dennis, co-founder and chief medical officer of Linear Health Sciences. “Expanding indication for the Orchid SRV to all IV settings will help improve outcomes for millions of patients every year.”
Dislodgement and associated IV treatment failures in the more than 342 million peripheral IVs administered in the U.S. each year1 are estimated to cost the American healthcare system more than $2 billion annually2. Dislodgement is most frequently caused by patient confusion or removal of the catheter, loose dressing or tape, or tubing becoming tangled in bed linens. Clinical simulation testing of 360 Orchid SRVs showed that the device prevented IV dislodgement by 91.1 percent across all test groups.
“The expanded indication from the FDA represents an acceleration of our commercialization efforts, as we look to create a continuum of care for vascular access,” said Dan Clark, co-founder and CEO of Linear Health Sciences. “In addition to improved care for patients, the Orchid SRV enables significant downstream cost savings, which benefits the entire healthcare ecosystem.”
Linear Health Sciences won an Innovative Technology Award for Orchid SRV from Vizient, making the device available to hospital customers through a non-exclusive contract with the group purchasing organization (GPO). Additionally, the device is available nationwide and across Canada. Qualified clinical evaluations of the Orchid SRV will continually quantify device utilization, driving Linear Health Science’s next generations of innovation.