Linear Health Sciences’ Orchid Safety Release Valve Receives Expanded Indication From FDA

October 17, 2023—Linear Health Sciences, an Oklahoma-based medical device company, announced it received an expanded indication from the FDA for its Orchid safety release valve (SRV) that allows the device to be used with all intravenous (IV) access methods.

According to the company, the Orchid SRV 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 2 weeks of age and older.

The Orchid SRV is a sterile, single-use connector for needle-free access that is intended to make the return to treatment fast, simple, and clean.

Dislodgement and associated IV treatment failures are 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% across all test groups, noted the company.

Linear Health Sciences advised that it won an Innovative Technology Award for Orchid SRV from Vizient, making the device available to hospital customers through a nonexclusive contract with the group purchasing organization. Additionally, the device is available throughout the United States and Canada.

The cofounders of Linear Health Sciences are CEO Dan Clark and Chief Medical Officer Ryan Dennis, MD.

“Maintaining vascular access is one of the most fundamental, yet most overlooked, treatment modalities in medicine today,” stated Dr. Dennis in the company’s press release. “Expanding indication for the Orchid SRV to all IV settings will help improve outcomes for millions of patients every year.”

Clark added, “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. In addition to improved care for patients, the Orchid SRV enables significant downstream cost savings, which benefits the entire health care ecosystem.”