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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameLIPOSORBER® LA-15 System
Classification Nameapheresis for focal glomerulosclerosis in adult and pediatric patients
Generic Nameapheresis for focal glomerulosclerosis in adult and pediatric patients
Applicant
Kaneka Pharma America, LLC
546 fifth ave., 21st floor
new york, NY 10036
HDE NumberH120005
Supplement NumberS026
Date Received12/16/2025
Decision Date08/26/2026
Product Code
PBN[ Registered Establishments with PBN ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the kaneka liposorber® la-15 system. This device is indicated for use in the treatment of pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when 1) standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments,are unsuccessful or not well tolerated and the patient has a gfr 60 > ml/min/ 1. 73m2; or 2) the patient is post renal transplantation.
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