The primary objective of the study is to demonstrate that the performance of the modified Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved Plasmat® Secura H.E.L.P Apheresis System for use under the approved indication of the acute reduction of LDL-cholesterol from the plasma in populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated.
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Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System.
Timeframe: Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..
Percent Change of the Pre and Post Treatment Value
Timeframe: Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24.