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Summary of Current Innovation: Seraph 100

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Summary of Current Innovation: Seraph 100

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The Seraph 100 recently won European regulatory approval to treat blood stream infections and sepsis.
ExThera, the company that developed Seraph 100, is based outside of Oakland, California.

The Seraph 100 was developed to reduce pathogens found in whole blood such as bacteria, viruses, and fungi through hemofiltration.

As the patient's blood flows through the filter, microbeads coated with molecular receptor sites bind to the pathogens through selective absorption.

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Seraph 100 Blood Filter

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ExThera selected the hemodialysis patient population as its first group for clinical investigation in its European clinical trial. The company has received Expedited Access Pathway designation from the FDA. for treating patients with bacteremia, and is finalizing a protocol for treating patients with viremia. U.S. clinical trials are expected to begin in the near future.

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-Reduce drug resistant pathogens
-In clinical trial, no adverse events occurred
-In clinical trial, there was a >40% reduction of pathogens
-One-time, 4 hour treatment
-Filter can be used with current extracorporeal equipment

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My top 5 strengths:
1. Harmony
2. Consistency
3. Learner
4. Achiever
5. Analytical

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August 12, 2019

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-Patient must require renal replacement therapy
-Extensive exclusion criteria
-Clinical trial was a small (15 participants), prospective, non-randomized study
-Still needs FDA approval in U.S. Currently, it is only available in Europe

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ExThera Seraph. (n.d.). Retrieved from http://www.extheramedical.com/exthera-seraph.

MedgadgetEditors. (2019, August 12). Seraph 100 Blood Filter For Blood Stream Infections Cleared in Europe |. Retrieved from https://www.medgadget.com/2019/08/seraph-100-blood-filter-for-blood-stream-infections.html.

Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis - Full Text View. (n.d.). Retrieved from https://clinicaltrials.gov/ct2/show/NCT02914132.

U.S. septicemia price tag totaled nearly $15.4 billion. (2012). AACN Bold Voices, 4(1), 11. Retrieved from https://search-ebscohost-com.ezproxy.uttyler.edu/login.aspx?direct=true&db=ccm&AN=104628108&site=ehost-live&scope=site

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As a Sepsis Coordinator, I was immediately intrigued by the  Seraph 100 Blood Filter. I have seen the complications of blood stream infections and sepsis first hand. Patients with drug resistant bacterial infections endure weeks of antibiotic treatment and once they are stable to return home, they will most likely need a PICC line and home health to continue managing their disease.

In treating these patients, IV broad spectrum antibiotics are administered within 1-3 hours of suspected sepsis. This, in return, gives concern to the rise of antibiotic resistant organisms and can also put a patient at risk for developing C. Diff. The idea that a patient's bacterial load in their blood can be reduced in just 4 hours is mind blowing. Blood stream infections have high morbidity and mortality rates, along with a hefty price tag. According to the AACN, in 2009, the cost of septicemia was nearly $15.4 billion (AACN, 2012).

I am eager to see the outcomes of the Seraph 100 in Europe.

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I chose my team based on strengths that would compliment mine, as well as enhance the success of implementing this new device.

Andrew (activator) was chosen for his ability to turn ideas into actions while being a source of energy for the group.
Carter (communication) was chosen to help balance Andrew who can sometimes speak before thinking. Carter has a charismatic personality that draws the audience in.
Matthew (maximizer) was chosen for his strength to bring the team together and drive excellence. He will help take the team to the "next level."
Sheila (strategic) was chosen for her ability to  identify strengths and weaknesses within the group and can think on her feet when plans change.
William (woo) was chosen for his ability to network and bring people together. He excels at breaking the ice and make connections with others.