Post Marketing Surveillance Study for LDL Apheresis Using H.E.L.P. Therapy

Detailed Summary

The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular events or interventions, angina, and serious unanticipated adverse effects. Laboratory assessments will be made to document low-density lipoprotein cholesterol (LDL-C) reduction and any effects on other blood components. Quality of life assessments will also be made. The study will also assess the modifications to the H.E.L.P. System, including: * use of a single heparin adsorber, instead of two smaller adsorbers; * change in the supplier of the ultrafilter (from Secon to Toray); * reduction in the number of blood lines from eleven to nine; * change from a single-layer to a two-layer precipitate filter. The safety and efficacy of the device specific to these modifications will be evaluated by comparing the safety and efficacy data from the patient registry to the data from the initial clinical study on the device as originally designed.

Study Details

Timeline

Interventions