Linear Health Sciences has received FDA clearance for an expanded indication of its Orchid Safety Release Valve (SRV), now allowing its use during blood and blood product transfusions for patients two weeks of age and older. This expansion builds upon the device's existing indication for intermittent or continuous infusion, addressing a critical need to maintain stable IV access during transfusions.
The Orchid SRV is designed as a sterile, single-use connector for needle-free access, intended to simplify and expedite the return to treatment while enhancing both patient and clinician experiences. The device's primary function is to prevent IV dislodgement, a common issue that leads to increased costs and complications in healthcare settings.
"The Orchid SRV has been shown to significantly reduce IV dislodgement and its associated costs and complications," stated Rob Headley, Vice President of Sales and Business Development at Linear Health Sciences. He emphasized that this expanded indication represents a significant advancement towards establishing a new gold standard of care, strengthening the company's competitive position, and substantially broadening its addressable market.
Addressing IV Dislodgement
According to Linear Health Sciences, approximately 25 million IV dislodgement events occur annually in the U.S., resulting in an estimated $2 billion in costs. These events are often caused by patient confusion, accidental catheter removal, loose dressings, or tangled tubing. The Orchid SRV aims to mitigate these issues, offering a proactive solution to safeguard IV access.
Jon Bell, MSN, RN, VA-BC, CEN, Emergency Department & Cardiopulmonary Services Director at Mount Desert Island Hospital, noted the importance of protecting IV access during blood administration, particularly for critical patients. "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 Bell. "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."
Clinical Acceptance and Cost Savings
Clinical evaluations of the Orchid SRV have demonstrated high acceptance rates, averaging over 92% across more than a dozen clinical sites. A case study at a large Northeast regional medical center revealed annualized cost savings of nearly $104,000 due to the reduction in IV dislodgement events, leading to the device's adoption throughout the facility.
Dennis Woo, RN, Interventional Vascular Access Specialist, highlighted the benefits of the expanded indication, stating, "Approval for blood transfusion is a huge step forward. 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."
Additional Agreements
Linear Health Sciences has also secured a contract with the U.S. Department of Veterans Affairs (VA) for the Orchid device, in collaboration with GS2. Furthermore, the Orchid SRV has received an Innovative Technology contract from Vizient, Inc., and a national group purchasing agreement for IV Therapy - Needleless Connectors with Premier, Inc., further solidifying its market presence and accessibility.
