Safety; Effectiveness - Ulthera Cellfina CM1 Instrucciones De Uso Del Sistema

Ulthera, Inc.
Gender
Male
Female
Other Demographics
Age (years)
BMI
Fitzpatrick Skin Type
Skin Type
Pre Treatment Cellulite Severity
Overall Severity Grade

Safety

The primary safety endpoint for the study was achieved as no Unanticipated Adverse Device Effects (UADE) and no
Serious Adverse Events (SAE) related to the Cellfina
2 minor, resolved adverse events (AE) in total related to the treatment or procedure: 1) a superficial wound created
from scratching at a treatment site, and 2) itching on the inner thighs from the compression garment.
Minor protocol specified treatment effects were observed as expected and none met the threshold of AE reporting
based on intervention or severity. Observations at the 3 month follow-up were limited to hemosiderosis, tingling, and
palpable areas of softness or firmness consistent with the healing mechanism. Hemosiderosis, which is common
with needle based septae release and can take up to 12 months to resolve
month follow-up and was not visible in the photographs.
subjects and expected from nerve stimulation (from healing). Consistent with the fluid transition to solid tissue
(desired mechanism of action) there were 6 reports of very small areas of "softness" that could be felt with
manipulation or deep palpation only and were not visible. Similarly, there were 8 reports of very small areas of
"firmness" that could be felt with palpation, but were only visible in 1 subject (as a slightly raised area). At 1 year the
observations were limited to 2 areas of palpable (not visible) areas of firmness. The common extent of these
observations is evident with needle based septae release
2-year or 3 year follow-ups.

Effectiveness

Effectiveness was evaluated by subject satisfaction and also by improvement assessments by independent physician
evaluation of subject photographs taken before and at 3 months, 1 year, 2 years, and 3 years after treatment. This
evaluation was managed by an independent firm in accordance with the study protocol. A total of three Physician
Evaluators were selected, individually trained, and monitored throughout the evaluation. Nothing about the sponsor,
the method of treatment, study, or Investigators was disclosed to the Physician Evaluators. In the evaluation, blinded
before (baseline) and after photographs were provided side by side in randomized orientation (L-R) and the Physician
Evaluators were asked to identify the baseline and after photographs, rate the overall improvement according to a
Global Aesthetic Improvement Scale (GAIS), and then score the number and depth of cellulite depressions in each
photograph according to a photonumeric scale. This scale was comprised of the definitions in Table 2 with an
accompanying set of Reference Slides illustrating each of the scores. For analysis, a Cellulite Severity Scale was
calculated from the Evaluator scores by the adding of scores for A (number) and B (depth) and subtracting 1 (offset
since there is no cumulative value of 1). The resulting 0-5 point Severity Scale provided a quantitative measure of
treatment effect. The Scale was converted to a commonly used 0-3 point Severity Grade as illustrated in Table 2
1007270IFU Rev D
Cellfina
Table 1. Subject Demographics
Characteristic
®
System
N = 55
0 (0%)
55 (100%)
Avg Median
41 42
25.2 24.5
I, II III
12 (22%) 25 (46%)
None Mild
0 (0%) 5 (9%)
®
System or procedure were observed in the study. There were
2
, was only reported by 1 subject at the 3
Minor infrequent areas of tingling were reported by 2
2
for cellulite and scars
User Manual
Min Max
25 55
18.3 34.6
IV V, VI
10 (18%) 8 (14%)
Moderate Severe
27 (49%) 23 (42%)
1
. No observations were noted at the
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