2/10/2022 - URGENT: MEDICAL DEVICE RECALL ‹LIPOSORBER© LA-15 SYSTEM Labeling›

Kaneka Medical America LLC is voluntarily recalling LIPOSORBER© LA-15 System Labeling. .

For more information please click on the link below
Customer Recall Notification and Response Letter with Appendices.pdf

Link for revised IFU, Operators manual, and patient guide
KP-05 IFU (FH,FSGS) (NEW).pdf
LA-15 IFU (FH,FSGS) S205H-9 (NEW).pdf
NK-M3R IFU (FH,ESGS) (NEW).pdf
Liposorber System Operators Manual (FH) (NEW).pdf
Liposorber System Operators Manual (FSGS) (NEW).pdf
Patient Guide(FSGS) (NEW).pdf

6/01/2021 - Kaneka and Asahi Intecc Announce Marketing Collaboration for i-ED Coil distribution in US

Kaneka and Asahi-Intecc have entered into an agreement for co-marketing activities to distribute i-ED COIL™ into Asahi Intecc’s sales channels in US. KANEKA collaborates with Asahi Intecc’s neurovascular sales and clinical staff to sell and marketing of I-ED COIL, including marketing material preparation, clinical support, and administration for consignment stock in hospitals. This agreement may also expand to include other product offerings in the future.

“This agreement will allow KANEKA to obtain a strong foothold in the US neurovascular detachable coil market with robust relationship to Asahi Intecc’s familiar accounts.”

3/28/19 - Kaneka Medical America LLC in the News

Kaneka Pharma America is pleased to announce that the FDA approved the modification of the indications for the use (IFU) of Kaneka’s LIPOSORBER® LA-15 system. This approval will allow more US patients to use our apheresis treatment to lower low-density lipoprotein cholesterol (LDL-C) levels. The FDA made the following modification:
The LDL-C cut-off in Group C is now reduced to 100 mg/dL from 160 mg/dL.

The LIPOSORBER IFU as of March 28, 2019:
The LIPOSORBER LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma of the following high-risk patient populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated:

• Group A – Functional Hypercholesterolemic Homozygotes with LDL-C >500 mg/dL;
• Group B – Functional Hypercholesterolemic Heterozygotes with LDL-C ≥300 mg/dL; and
• Group C – Functional Hypercholesterolemic Heterozygotes with LDL-C ≥100 mg/dL and either documented coronary artery disease or documented peripheral artery disease.

In accordance with FDA requirements, Kaneka will revise our labeling to reflect the approved new indications for use. While we make those updates, this new indication is effective as of March 28, 2019. Attached is the FDA’s approval letter for more information. Kaneka believes this development will assist physicians in their treatment plans for patients with severe hypercholesterolemia. If you have any questions, please contact us at 612-590-9446.

Sincerely,
Naoto Oyama
President, Kaneka Medical America LLC

Read the FDA Letter

2/14/19 - Kaneka Medical America LLC in the News

Look for us at the National Lipid Association Conference in Portland, OR on February 22-24 at booth 104.