Linear Health Sciences has earned expanded indication from the U.S. Food and Drug Administration (FDA) for its Orchid Safety Release Valve (SRV).
 
Orchid SRV is a sterile, single-use connector for needle-free access. The IV dislodgement-prevention device is indicated for patients aged two weeks and up during intermittent or continuous infusion. The FDA nod expands its use to transfusion of blood or blood products.
 
The device addresses the estimated 25 million U.S. dislodgement events, which most commonly result from patient confusion or catheter removal, loose dressing or tape, and/or tubing becoming tangled in bed linens.
 
“The Orchid SRV has been shown to significantly reduce IV dislodgement and its associated costs and complications,” said Rob Headley, VP of sales and business development at Linear Health Sciences. “This, our third expanded indication, reflects a significant shift in the potential for a new gold standard of care, creates a valuable functional moat competitively, and expands our total addressable market exponentially.”
 
The company was awarded a U.S. Dept. of Veterans Affairs (VA) contract for the Orchid device earlier this year, in partnership with G2. Linear Health said over a dozen clinical sites have evaluated Orchid, finding clinical acceptance rates to average over 92%.
 
One Northeast regional medical center achieved annual cost savings of almost $104,000 and clinical acceptance rate of over 97%, the company boasted.
 
The Orchid SRV has also received an Innovative Technology contract from Vizient Inc., the nation’s largest member-driven healthcare performance improvement company, and was recently awarded a national group purchasing agreement for the IV Therapy – Needleless Connectors category with Premier Inc.