Use Instructions

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Current Clinical Summary: FIX-HF-5C2
Introduction
Prior versions of the OPTIMIZER device used under the current US IDE have required
sensing of atrial depolarization via an atrial lead to properly time the delivery of CCM
pulses. Accordingly, the presence of atrial fibrillation or flutter imposed a technical
limitation to the delivery of CCM signals. The current version of the OPTIMIZER, the 2-
Lead OPTIMIZER Smart, has overcome the need for atrial sensing while maintaining
safe and effective delivery of CCM to the ventricle. The 2-Lead OPTIMIZER Smart
reduces the total lead requirement from 3-leads to 2-leads enabling CCM therapy to be
delivered to a broader range of symptomatic HF patients while reducing the total
hardware burden and corresponding lead-related adverse events on all patients receiving
CCM.
The most frequent complications observed in the FIX-HF-5 and FIX-HF-5C trials were
lead dislodgment, lead insulation breech, and lead fracture requiring an additional
surgery to revise or replace the lead. Similarly, such lead-related complications are the
most frequently cited complications for CRT, ICD, and pacemaker devices. Therefore, the
ability to reduce the total number of leads needed for any given device, such as the
OPTIMIZER Smart, has the potential to reduce the overall complication rate of that
device. Improving the inherent safety of the OPTIMIZER Smart will allow physicians to
expand its use thereby helping more patients with chronic heart failure.
Overview of Study Design
The FIX-HF-5C2 study was a multicenter, prospective, single-arm treatment only study of
the 2-Lead configuration of the OPTIMIZER Smart System. Sixty patients were enrolled
and implanted with the OPTIMIZER Smart System. The primary effectiveness endpoint
was an improvement in exercise tolerance as measured by peak VO2 obtained on
cardiopulmonary exercise testing (CPX). CPX data were evaluated by an independent
core laboratory. Results for subjects implanted with the OPTIMIZER Smart were
compared to the peak VO2 results for the subjects in the control group of the FIX-HF-5C
study with respect to mean change in peak VO2 at 24-weeks from baseline.
The secondary effectiveness endpoint for the FIX-HF-5C2 study was an assessment of
the average daily amount of CCM therapy provided over the 24-week study. A
comparison between the OPTIMIZER 2-lead device subjects in the FIX-HF-5C2 study
was made to the OPTIMIZER 3-lead device subjects of the FIX-HF-5C study to
determine whether or not there was a difference between the therapy provided by the two
device configurations.
The primary safety endpoint in the FIX-HF-5C2 study was the percentage of subjects
experiencing an OPTIMIZER device or procedure related complication through the 24-
week follow up period. Complications were adjudicated by an independent events
committee.
Overview of Methodology
Sites identified potential patients from their clinic’s chronic heart failure population. The
target patient population consisted of subjects with ejection fractions from 25 to 45%
(inclusive) whose symptoms were consistent with NYHA functional class III or ambulatory
NYHA Class IV. Informed consent was obtained from potential subjects who were then
enrolled in the study to undergo baseline screening testing to determine eligibility for the
study. Baseline screening exams included: a medical history, physical examination,
medication history, blood testing, cardiopulmonary exercise testing (CPX) to determine
peak VO2, echocardiography to determine left ventricular ejection fraction (LVEF), 12-
Lead ECG, and an NYHA Class assessment. The CPX and echocardiography tests were
evaluated by an independent core laboratory.
Subjects that passed baseline testing and eligibility criteria were scheduled to have the
OPTIMIZER Smart with 2-leads implanted as soon as possible. Subjects then returned to
the clinic for evaluation at 2 weeks, 12 weeks, and 24 weeks following the initial
implantation. At the 12-week and 24-week visits, subjects completed a physical