Introduction

The LIPOSORBER^® 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:

• Patients with LDL-C >300 mg/dl
• Patients with LDL-C >200 mg/dl and documented coronary heart disease (CHD).