Additional Warnings; Precautions; Risks; Clinical Studies - Ulthera Cellfina CM1 Instrucciones De Uso Del Sistema

Ulthera, Inc.

ADDITIONAL WARNINGS

Additional boxed warnings are provided within the Directions for Use section for specific procedural steps.

PRECAUTIONS

 ®
The Cellfina System should only be used by physicians who read and understood this User Manual.

To protect sterility after opening, the blade and needle should remain covered prior to use.

RISKS

Potential adverse events are those typically associated with anesthesia infiltration, liposuction, subsurface tissue
cutting, and other methods of body sculpting

Abscess

Anetoderma

Anxiety (nervousness,
apprehension)

Blanching (generalized
whiteness)

Blurred or double vision

Bleeding

Dizziness, drowsiness,
confusion

Ecchymosis/bruising

Fluid accumulation (swelling,
edema)

Fluid extravasation

CLINICAL STUDIES

Feasibility clinical testing of the Cellfina
received treatment with the device. There were no serious or unanticipated adverse events related to the device or
procedure, and the effectiveness endpoints were achieved.
persistent treatment effects (seromas) were prevented by avoiding connecting treatment sites at the same depth,
which created larger dissections that took longer to heal.
evaluated in a pivotal clinical study.
The pivotal study was a prospective, multi-center, non-randomized open label, safety and effectiveness study with
treatment of 55 subjects in 3 US centers. All subjects served as their own control and underwent a single treatment
®
with the Cellfina System. All subjects underwent follow-up assessments at 3 days, 14 days, 1 month, 3 months, 6
months, 1 year, 2 years, and 3 years post treatment.
inclusion to female subjects between the ages of 25 and 55 with moderate to severe cellulite and BMI less than 35.
Actual subject demographics are summarized in Table 1. Subjects were seen at regular follow-ups out to 3 years
post-treatment and evaluated by a physician for effects of the treatment. The subjects were asked to rate their
satisfaction with their cellulite appearance and pain. Photographs were taken in accordance with a protocol-specific
photography procedure at baseline and each follow-up. An independent and blinded review of the photographs
before treatment and at 3 months, 1 year,2 years, and 3 years was used to verify the effectiveness of the procedure.
The average number of released sites per subject was 13 and ranged from 6 to 25. Of the released sites, 86% were
completed at 6 mm depth and 14% at 10 mm. The average treatment time was 42 minutes and ranged from 25 to 63
minutes.
1007270IFU Rev D
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Cellfina System
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including:

Hematoma

Hemosiderosis

Hyperpigmentation

Hypopigmentation

Induration, fibrosis

Infection

Inflammation / generalized
redness

Nausea/vomiting

Numbness, tingling, or sensitivity
change

Petechiae or purpura (vacuum
acquisition marks)
®
System was conducted in 1 OUS and 1 US center where 56 subjects
This refined treatment technique was prospectively
The subject inclusion/exclusion criteria intended to limit

Red Spots (from needle
punctures)

Redness, erythema, or rash

Scarring or keloid formation

Sensations of heat or cold

Seroma

Skin necrosis

Skin surface convexity,
depression or other irregularity

Soreness or discomfort - pain

Tinnitus

Toxic, allergic, or other
reaction from the injected
anesthetic
This prior clinical testing demonstrated that more
User Manual
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