Key result
HELP Futura system demonstrates high clinical safety and flexibility for extracorporeal LDL reduction.
Why the study?
A new HELP Futura system was developed to upgrade the standard HELP Secura system and required evaluation to confirm comparable clinical results.
Does the HELP Futura system safely and effectively reduce LDL, Lp(a), and fibrinogen compared to the standard HELP Secura system?
Does the HELP Futura system safely and effectively reduce LDL, Lp(a), and fibrinogen compared to the standard HELP Secura system?
The upgraded HELP Futura apheresis system is safe and effective for reducing LDL, Lp(a), and fibrinogen in clinical routine.
May support upgraded HELP apheresis with sterile solutions; confirms short-term equivalence but leaves open larger randomized validation.
Heparin extracorporeal low-density lipoprotein precipitation (HELP) Futura is a new development in the standard HELP Secura system that has been in clinical practice for more than 15 years. Based on this experience, a HELP Upgrading system was first evaluated in a clinical trial to confirm the same clinical results as in the standard system. The upgraded procedure worked with industrially prepared sterile dialysis solutions instead of the reverse osmosis device. The conclusion of the study was that the reductions of low-density lipoprotein, lipoprotein (a), and fibrinogen and the correction of the acid-base balance were comparable with the results of the standard system. As a second step, the HELP Futura system was evaluated in a clinical acceptance test and in a field test in the daily routine. After approximately 2,000 treatments on 35 patients, we can conclude that the HELP Futura procedure has reached a mature phase with a high degree of clinical safety and flexibility.
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M. Susca (2001) studied this question. HELP Futura system vs. standard HELP Secura system was evaluated on Clinical safety and flexibility. The HELP Futura system demonstrated a high degree of clinical safety and flexibility after approximately 2,000 treatments in 35 patients.
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