Humanitarian Device Exemption (HDE)

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 Name: Liposorber LA-15 System
• Classification Name: apheresis for focal glomerulosclerosis in adult and pediatric patients
• Generic Name: apheresis for focal glomerulosclerosis in adult and pediatric patients
• Applicant: Kaneka Pharma America LLC; 546 fifth avenue, 21st floor; new york, NY 10036
• HDE Number: H170002
• Supplement Number: S001
• Date Received: 05/09/2018
• Decision Date: 03/04/2019
• Product Code: PBN [ Registered Establishments with PBN ]
• Advisory Committee: Gastroenterology
• Supplement Type: normal 75 day track
• Supplement Reason: postapproval study protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
The pma was approved on 3/20/2018 with the following condition of approval:osb lead hde post-approval study report – new enrollment pas for liposorber® la-15 system, adults: the office of surveillance and biometrics (osb) will have the lead for studies initiated after device approval. This study will be conducted as per protocol outline dated october 20, 2017, included in h170002/a001. You have agreed to conduct a study as follows:the purpose of the study is to evaluate the long-term safety and probable benefit of the liposorber® la-15 system for the treatment of patients who have fsgs with a gfr ? 60 mi/min/1. 73 mm2 accompanied by nephrotic syndrome in which standard treatment options are unsuccessful or not well tolerated or for the treatment of post renal transplant patients with nephrotic syndrome associated with primary fsgs. You agree to modify the ongoing post-approval study that was required as condition of approval for the pediatric indication (approved under h120005), to include 35 newly enrolled adult subjects (in addition to the requirement of 35 subjects for the pediatric indication). This will be a prospective, multicenter, single arm study in 3 to 10 clinical centers in the united states. The study participants will be followed for 24 months after the completion of the final apheresis procedure. The study visits will be as follows: pre-procedural exams and laboratory tests, approximately 9 weeks of study apheresis procedures, and 1-, 3-, 6-, 12- and 24-month follow-up office visits. The primary objectives of this study are to confirm the safety and probable benefit of the liposorber® la-15 system in relieving nephrotic syndrome, defined as urine protein: creatinine ratio (up/c) > 2. 0 (gram protein per gram creatinine) with a first morning void urine sample, associated with refractory primary fsgs at 1 month after the final apheresis treatment. The primary probable benefit endpoint is the percent of patients who show complete or partial remission at 1 mo.