Medical device company Linear Health Sciences has received U.S. FDA clearance and Health Canada approval of its Orchid SRV, a tension-activated breakaway safety release valve designed to reduce the risk of IV catheter failure and replacement in hospitals.
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Complete primary catheter on white background
The company also announced the simultaneous launch of Orchid SRV Type D, a Class I device based on the same proprietary platform technology for use in surgical/wound, nephrostomy, and abscess drainage.
According to a study published in J-AVA, 95% of 1,561 U.S. clinicians surveyed agreed that IV dislodgements continue to pose significant safety risks for patients and hospitals. In fact, reports have shown that, of the 342 million peripheral IVs in the U.S. each year, up to 10% may dislodge, costing more than $2 billion annually. Dislodgement is most frequently caused by patient confusion or removal of the catheter, loose dressing or tape, or tubing becoming tangled in bed linens.
Nancy Moureau, an internationally recognised expert in vascular access practice who conducted the survey, said: “Despite great advances in other areas of medicine, there is still a significant unmet need for improved safety in IV therapy. With an estimated 90% of hospitalised patients requiring treatment using IV therapy and a need to maintain those devices, it is time for a product like the Orchid SRV, not only to increase patient and staff safety but also to reduce cost associated with accidental dislodgment.”
The Orchid SRV is a sterile, single-use connector for needle-free access that, when activated, aims to make return to treatment fast, simple, and clean, while improving both the patient and clinician experience. Clinical simulation testing of 360 Orchid SRVs showed that 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.
Dr. Ryan Dennis, Linear Health Sciences co-founder and CEO, said: “We designed Orchid SRV to disrupt an area of medicine long overlooked and due for positive change. We expect our current and future pipeline of platform technology-based products to help change the standard of practice in vascular access and medical tubing applications as a whole.”
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 lbs.) 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.
Dan Clark, co-founder, president, and COO of Linear Health Sciences added: “The power of our breakaway safety release valve technology platform has been demonstrated and is now validated by both the FDA’s and Health Canada’s clearance of the Orchid SRV. Our platform expands with the addition of Orchid SRV Type D, and we look forward to developing new use cases for it in other areas of medical tubing in the future.”
