New York, January 29, 2025
We are pleased to announce an important update regarding Kaneka’s LIPOSORBER® LA-15 System Indications for clinically diagnosed Familial Hypercholesterolemic patients. As part of our ongoing commitment to advance patient care and support healthcare providers in properly managing these patients, we have received approval for improved indications that enhance the utility of our system in clinical settings.
This update affects Group C and Group D of the indications and have been updated as follows:
These updates are expected to broaden the application of the LIPOSORBER LA-15 System in treating clinically diagnosed Familial Hypercholesterolemic patients with elevated LDL-C and/or Lp(a) who have documented cardiovascular disease. We are committed to supporting our customers throughout this transition and will be providing further information and resources about the updated indications, including training opportunities and revised clinical support materials.
FDA approved our premarket approval application (PMA) 180-day supplement for this labeling change on January 24, 2025. The revised labeling of the LIPOSORBER LA-15 System will now include the following Indications for Use Statement:
If you have any questions or require further assistance, please do not hesitate to reach out to your Sales Account Representative, Medical Affairs Representative, or contact our Customer Support Team.
Thank you for your continued trust in our products and commitment to patient care.
Sincerely,
Takuji Hasegawa
Executive Vice President
