Linear Health Sciences
Linear Health Sciences, a medical device company that has developed a proprietary, breakaway safety valve platform, has announced that it received an expanded indication for its Orchid Safety Release Valve (SRV) from the U.S. Food & Drug Administration (FDA).
The Orchid SRV is a sterile, single-use connector for needle-free access that makes return to treatment fast, simple, and clean, and improves both the patient and clinician experience. It is indicated for patients two weeks of age and older during intermittent or continuous infusion, and can now be used during the transfusion of blood or blood products.
“The Orchid SRV has been shown to significantly reduce IV dislodgement and its associated costs and complications,” said Rob Headley, Vice President 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 estimated 25 million U.S. dislodgement events, which are most frequently caused by patient confusion or removal of the catheter, loose dressing or tape, and/or tubing becoming tangled in bed linens, are projected to cost 2 billion USD annually according to the company.
“It’s crucial to protect IV access during blood administration for critical patients, to ensure a stable and uninterrupted flow of blood products, which can be life-saving,” said Jon Bell, MSN, RN, VA-BC, CEN, emergency department & cardiopulmonary services director at Mount Desert Island Hospital in Bar Harbor, Maine. “Orchid SRV can be used to safeguard the patient’s line even during blood administration, and is an innovative and valuable lifeguard for those who are already in a fragile condition.”
Read more: Linear expands commercialisation of Orchid SRV device
Linear Health Sciences earlier this year was awarded a contract by the U.S. Dept. of Veterans Affairs (VA) for the Orchid device, in partnership with GS2. Additionally, more than a dozen clinical sites have evaluated Orchid, with clinical acceptance rates averaging more than 92%. A growing number of hospitals and healthcare systems are evaluating the device, recognising their need for the expanded protection that the Orchid SRV can provide.
One case study at a large, Northeast regional medical centre showed annualised cost savings of nearly 104,000 USD, and a clinical acceptance rate of more than 97%, leading to the whole-house adoption of the Orchid SRV.
“Approval for blood transfusion is a huge step forward,” said Dennis Woo, RN, interventional vascular access specialist. “Reducing instances of catheter hub exchange for procedures as common as transfusion will greatly minimize exposure in the hematology/oncology population, while continuing to reduce risk of IV loss."
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.
