Magnolia Medical Announces (FDA) 510(k) Clearance of New Configurations and the Entire Steripath® Gen2 Initial Specimen Diversion Device® Product Family

Companies in the Global Vaccine Delivery Devices Market Expedite Product Innovations to Stay at Forefront in the Market in the COVID-19 Pandemic

Fact.MR has recently compiled a report, which reveals that the vaccine delivery devices market globally is projected to reflect an impressive CAGR over the forecast period, 2017 – 2022.

Sirtex Medical and BlackSwan Vascular Report 1st Patient Enrolled in Pivotal LAVA Study

The LAVA Study, which stands for Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature, is a prospective, multicenter single-arm study of 113 subjects at 20 investigational sites in the U.S.

Cohen Children’s Medical Center: Covid-19 Teen Returns to Thank the Doctor Who Saved Her Life

It was nothing but bright sunshine at Cohen Children’s Medical Center when Karla Duarte, the first teenager in American to be treated for COVID-19 with extracorporeal membrane oxygenation (ECMO) stopped by to thank the medical team on the one-year anniversary of her discharge.

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 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.


References

  1. M. Rupp, et al. Clinical Infectious Diseases (2017)
  2. M. Bell, et al. Journal of Emergency Nursing (2018)
  3. See full Instructions for Use included in device packaging
  4. Patton, R., et al. Journal of Clinical Microbiology (2010)
  5. Zwang, O., et al. Journal of Hospital Medicine (2006)
  6. Patton, R., et al. Infection Control & Hospital Epidemiology (2016)
spot_img

DON'T MISS

Related Articles