CORRECTING and REPLACING Linear Health Sciences Announces U.S. FDA Clearance and Health Canada Approval of Its Orchid Safety Release Valve (SRV)

CORRECTING and REPLACING Linear Health Sciences Announces U.S. FDA Clearance and Health Canada Approval of Its Orchid Safety Release Valve (SRV)




CORRECTING and REPLACING Linear Health Sciences Announces U.S. FDA Clearance and Health Canada Approval of Its Orchid Safety Release Valve (SRV)

Device Intended to Reduce Risk of IV Catheter Failure and Replacement in Hospitals; Sister Product Orchid SRV-Type D for Drainage to Launch Simultaneously

OKLAHOMA CITY–(BUSINESS WIRE)–#FDA–Please replace the release with the following corrected version due to the removal of paragraph eight (“Linear Health Sciences won an Innovative Technology Award for Orchid SRV from Vizient, and the device will be offered to hospital customers through a non-exclusive contract with the group purchasing organization (GPO). Qualified clinical evaluations of Orchid SRV will continually quantify device utilization and drive Linear Health Science’s next generations of innovation”).

The updated release reads:

LINEAR HEALTH SCIENCES ANNOUNCES U.S. FDA CLEARANCE AND HEALTH CANADA APPROVAL OF ITS ORCHID SAFETY RELEASE VALVE (SRV)

Device Intended to Reduce Risk of IV Catheter Failure and Replacement in Hospitals; Sister Product Orchid SRV-Type D for Drainage to Launch Simultaneously

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. 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 percent 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 year1, up to 10 percent may dislodge2, costing more than $2 billion annually3. Dislodgement is most frequently caused by patient confusion or removal of the catheter, loose dressing or tape, or tubing becoming tangled in bed linens.

“Despite great advances in other areas of medicine, there is still a significant unmet need for improved safety in IV therapy,” said Nancy Moureau, PhD, RN, CRNI, CPUI, VA-BC, an internationally recognized expert in vascular access practice who conducted the survey. “With an estimated 90 percent of hospitalized 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, makes 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 percent across all test groups. The Orchid SRV is indicated for use during direct injection, intermittent infusion, and continuous infusion.

“We designed Orchid SRV to disrupt an area of medicine long overlooked and due for positive change,” said Dr. Ryan Dennis, Linear Health Sciences co-founder and CEO. “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.

“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,” said Dan Clark, co-founder, president, and COO of Linear Health Sciences. “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.”

About Linear Health Sciences

Linear Health Sciences is a medical device company that has developed a proprietary, breakaway safety valve technology designed to improve the use of medical tubing in hospitals. The platform technology was developed to increase the safety and satisfaction of patients, caregivers, and healthcare facilities, while dramatically reducing costs. The company’s initial products include the Orchid SRV for use in IV catheter therapy and the Orchid SRV Type D device for use in surgical/wound, nephrostomy and abscess drainage. For more information, visit linearsciences.com.

References:

1 iData research report

2 “The Peripheral Intravenous Catheter Journey: A Prospective Cohort Study of 1000 Patients.” Podium presentation by Nicole Marsh, RN, and Claire Rickard, RN, PhD, AVA 2017 annual meeting

3 Helm, et al. “Accepted but unacceptable: peripheral IV catheter failure” J Infus Nurs May-Jun 2015;38(3):189-203. doi: 10.1097/NAN.0000000000000100

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Sam Choinski

Pazanga Health Communications

schoinski@pazangahealth.com
(860) 301-5058