Linear Health Sciences Announces Expanded Indication for Orchid Safety Release Valve

Device Intended to Reduce Risk of IV Catheter Failure and Replacement in Hospitals Now Cleared for All IV Access Methods

Medical device company Linear Health Sciences today announced it received an expanded indication from the U.S. Food & Drug Administration (FDA) for its Orchid SRV™ safety release valve. The expanded indication means that the Orchid SRV may now be used with all IV access methods.

The Orchid SRV is a sterile, single-use connector for needle-free access that, when activated, makes return to treatment fast, simple, and clean, while improving both the patient and clinician experience. It 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 two weeks of age and older.

“Maintaining vascular access is one of the most fundamental, yet most over-looked, treatment modalities in medicine today,” said Dr. Ryan Dennis, co-founder and chief medical officer of Linear Health Sciences. “Expanding indication for the Orchid SRV to all IV settings will help improve outcomes for millions of patients every year.”

Dislodgement and associated IV treatment failures in the more than 342 million peripheral IVs administered in the U.S. each year1 are estimated to cost the American healthcare system more than $2 billion annually2. Dislodgement is 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 percent across all test groups.

“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,” said Dan Clark, co-founder and CEO of Linear Health Sciences. “In addition to improved care for patients, the Orchid SRV enables significant downstream cost savings, which benefits the entire healthcare ecosystem.”

Linear Health Sciences won an Innovative Technology Award for Orchid SRV from Vizient, making the device available to hospital customers through a non-exclusive contract with the group purchasing organization (GPO). Additionally, the device is available nationwide and across Canada. Qualified clinical evaluations of the Orchid SRV will continually quantify device utilization, driving Linear Health Science’s next generations of innovation.

Medical Device News Magazine
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.

By using this website you agree to accept Medical Device News Magazine Privacy Policy

Exit mobile version