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LDL Apheresis Receives Expanded FDA Approval

Monday, June 4, 2018   (1 Comments)
Posted by: ASFA Head Office
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The Center for Devices and Radiological Health (CDRH) of the FDA has approved Kaneka Pharma America’s humanitarian device exemption (HDE) application for the LIPOSORBER® LA15 System to expand the indication to include adult patients with nephrotic syndrome. The LIPOSORBER® LA-15 is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when 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 the patient is post renal transplantation.

More information on this approval can be found here.

Comments...

christian g. schrock says...
Posted Sunday, June 10, 2018
What is the status of FDA approval for treatment of Hyperlipoproteinemia Lp(a)? Christian G. Schrock MD Lp(a)CARE cgschrock@gmail.com