Magnolia Medical Receives FDA 510(k) Clearance for Expanded Steripath Gen2 Product Family
Magnolia Medical Receives FDA 510K Clearance for Expanded Steripath Gen2 Product Family
Products become the first and only indicated to reduce blood culture contamination
[ Seattle, WA – March 5, 2020 ] – Magnolia Medical today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of new configurations and the entire Steripath® Gen2 Initial Specimen Diversion Device® product family.
Extensive clinical data demonstrating the performance achieved with Steripath was evaluated by the FDA. This data included peer-reviewed controlled studies published in leading medical journals including Clinical Infectious Diseases1 (CID) and the Journal of Emergency Nursing2 (JEN) demonstrating significant reductions in blood culture contamination with Steripath compared to standard method controls.
At the University of Nebraska Medical Center (UNMC), Steripath demonstrated an 88% reduction in blood culture contamination down to 0.2% in the Emergency Department compared to standard method controls sustained for the one-year study period. This performance represented a 92% reduction compared to the pre-intervention period.
Steripath performance across four Lee Health Emergency Departments over a 7-month study period spanning 41,685 blood cultures demonstrated an 83% reduction in blood culture contamination compared to standard method controls with both venipuncture and IV-start configurations of Steripath Gen2.
These clinical results supported Steripath’s FDA-cleared indications for use to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion. Additionally, components of the Steripath Gen2 system may be used for infusion following sample collection, consistent with the Instructions for Use.3
Steripath is the first and only cleared device indicated to reduce blood culture contamination.
“As the inventors of the blood culture diversion device category, we have focused heavily on development of robust clinical data to demonstrate the sustained performance of Steripath,” said Greg Bullington, CEO of Magnolia Medical. “We appreciate the rigor of the FDA review process that resulted in this clearance and specific indications for use.”
The patented Steripath Gen2 ISDD® platform integrates user-controlled negative pressure to divert and sequester the initial 1.5 to 2.0 mL of blood collected for culture, the portion known to most likely contain contaminants.4 The device has been demonstrated effective for use with blood cultures drawn via both venipuncture and peripheral IV starts.2
Each year, tens of millions of patients in the U.S. require a blood culture test for diagnosis of sepsis and other bloodstream infections. On average, 3% of these tests are false-positive due to contamination.5 These false-positive results place over 1.2 million patients at risk of a misdiagnosis for sepsis.6
Steripath is a clinically proven solution to address this significant hidden problem in healthcare – the misdiagnosis of sepsis. Improving the accuracy of diagnostic test results for sepsis may reduce unnecessary antibiotic treatment to address the growing threat of antibiotic-resistance and reduce hospital costs.
About Magnolia
Magnolia Medical Technologies is a medical device company that develops, manufactures and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency and predictability of critical in vitro diagnostic (IVD) laboratory tests. Magnolia Medical invented and patented the initial specimen diversion technique (ISDT™) and device (ISDD®) for blood culture collection and contamination prevention. The Steripath ISDD has been shown in clinical studies published in leading peer-reviewed medical journals to significantly reduce blood culture contamination — helping healthcare providers decrease false-positive diagnostic results for sepsis and resulting unnecessary and inappropriate antibiotic use. This can reduce the risk of Clostridium difficile infections, multi-drug-resistant organisms and other antibiotic-related complications, hospital length of stay, associated healthcare-acquired infections and hospital-wide costs.1,2,3,4,5,6 The company has amassed an intellectual property portfolio protecting its technology and products, including more than 60 issued method, apparatus and design patents with more than 50 additional patent applications pending. For more information, visit www.magnolia-medical.com.
References:
Rupp, et al. Clinical Infectious Diseases (2017)
Bell, et al. Journal of Emergency Nursing (2018)
See full Instructions for Use included in device packaging
Patton, R., et al. Journal of Clinical Microbiology (2010)
Zwang, O., et al. Journal of Hospital Medicine (2006)
Patton, R., et al. Infection Control & Hospital Epidemiology (2016)