Steripath Gen2 is an FDA approved blood culture diversion device, integrated with preassembled syringe intended for reducing blood culture contamination
Magnolia Medical Technologies, a medical devices development company, has launched its new Steripath Gen2 Initial Specimen Diversion Device with integrated syringe.
The new Steripath Gen2 with integrated syringe is an advanced solution for reducing blood culture contamination, and is optimised for the difficult intravenous access (DIVA) or ‘hard stick’ patient population and syringe collection protocols.
Magnolia Medical CEO Greg Bullington said: “We are pleased to introduce the first FDA-cleared initial specimen diversion device with integrated syringe.
“This new product introduction represents an important step forward for the Steripath product family as we expand the tools available to help nurses, phlebotomists and healthcare workers address unique needs for specific patient circumstances.”
Steripath Gen2 platform will deploy negative pressure to divert and sequester the blood
The Steripath Gen2 platform is said to integrate user-controlled negative pressure to divert and sequester the initial 1.5 to 2.0 mL of blood collected for culture, which is most likely to contain contaminants.
In addition, the device will address the misdiagnosis of sepsis, and improves the accuracy of diagnostic test results for sepsis to reduce unnecessary antibiotic treatment.
Steripath Gen2 with integrated syringe will provide the healthcare workers with precise control to collect blood samples from patients with compromised vasculature. The device will benefit hospitals that require syringe collection for blood culture.
In addition, the company’s patented Steripath Gen2 ISDD product portfolio, which includes both direct-to-media and syringe configurations, are the only FDA 510(k) approved devices for reducing blood culture contamination.
FDA has approved the device with exclusive indication based on peer-reviewed clinical studies, which underlined the device’s capability to reduce blood culture contamination.
Magnolia Medical is engaged in developing, manufacturing and marketing advanced blood and bodily fluid collection devices to facilitate improvement in the accuracy, consistency and predictability of critical laboratory tests.