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# FDA Accepts Spectral Medical PMA for Sepsis Device
- URL: https://www.fdaweb.com/fda-accepts-spectral-medical-pma-for-sepsis-device/
- Published: 2017-07-24T12:00:00.000Z
- Updated: 2026-09-14T22:35:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139198

FDA has accepted for review a Spectral Medical rolling PMA for Toraymyxin, indicated for treating patients with septic shock. Toraymyxin is described by the company as a polymyxin B extracorporeal direct hemoperfusion adsorption column that is effective in removing endotoxin in the bloodstream. Toraymyxin has been approved and marketed by Toray Industries in Europe and Japan since 2002 and 1994 respectively. Spectral holds the exclusive rights for Toraymyxin in the U.S. and Canada, and is currently conducting a Phase 3 clinical trial for severe sepsis and septic shock, the company says.

  
The most recent results from a randomized controlled trial (the EUPHAS - Early use of polymyxin B hemoperfusion in abdominal sepsis (surgery) trial) were published in the *Journal of the American Medical Association* ([JAMA. 2009; Vol. 301 No. 23, 2445-2452](http://jama.jamanetwork.com/article.aspx?articleid=184078&ref=fdaweb.com)). “The results demonstrated that Toraymyxin adsorbs endotoxin from the bloodstream, and when added to conventional therapy, significantly improved hemodynamics and organ function,” Spectral Medical says.