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The selected treatment areas should be prepped and draped using standard center methods for
dermatologic surgery.
Anesthesia Delivery
The Cellfina
be used with a manual syringe system labeled for the introduction of local anesthesia.
An anesthetic solution should be compounded and introduced, per physician direction. In the pivotal
clinical study of the Cellfina
Anesthesia delivery should extend beyond the limits of the marked areas for release.
The area of anesthesia delivery is greater than the release area with each application of the Vacuum
Handpiece. There will be fewer anesthesia sites typically than release sites. For ease of use, it is
recommended that anesthesia be delivered at the shallower depth, 6 mm, even with intended release of
adjacent sites at multiple depths.
Overlap the anesthesia sites whenever possible such that the entry of the adjacent site is within a
previously infiltrated area to minimize pain
Subcutaneous Tissue Release
The number of sites necessary to treat all the areas will depend on the size of the patient and severity
or number of depressions. Priority should be given to those areas most visible and/or troubling to the
patient. Note: the maximum number of released sites was 25 in the pivotal study and the safety of
retreatment of the same depression or adjacent areas following treatment using the Cellfina
has not been established.
Develop the layout of released sites based on the areas marked and areas of release, visible on the
Vacuum Handpiece lid.
Use the shallower 6 mm depth as the default, and select the 10 mm depth to avoid connecting release
sites at the same depth.
Rotate the hand piece so the entry point at an alternate depth is not within a previously released area to
avoid inadvertent site connection, as the blade entry region is shallower.
Avoid treating areas that have creases or depression-like appearance not due to fibrous tissue
retraction (e.g., skin folds, skin laxity and/or lines between fat compartments). These creases present
as elongated lines vs more circular depressions and are more common on the posterior thighs.
Avoid treating on, and do not cross the gluteal crease where the buttock meets the upper and posterior
thigh or extension of this crease to the upper lateral thigh toward the hip.
Depending on the anesthesia volume, the released sites may leak for several hours. Kneading or gentle
massaging of the areas post treatment will help to express excess fluid prior to bandaging. Sterile
gauze pads held in place with the application of micropore bandages and compressive garments are
recommended following the procedure.
Post-treatment Care and Management of Complications
Antibiotic use before, during or after Cellfina
Pain may occur during the first days of the postoperative period and can be controlled with common
analgesics such as acetaminophen.
Compressive garments should be worn as often as possible for the first 2 weeks post-treatment.
Light physical activity is allowed in the first 30 days, but extreme physical activity should be avoided
during this time.
Hematomas, ecchymosis, and some hemosiderosis are expected. None of these were visible at 3
months in the pivotal clinical study.
Seromas can occur with overtreatment by connection/overlap of treatment sites. Seroma incidence was
eliminated by avoiding the overlap or connection of release sites at the same depth.
Palpable areas of firmness (or softness) are expected. Patients are usually reassured when they are
told that these areas are reported to be desirable for correcting the depressions that previously existed.
1007270IFU Rev D
Cellfina
®
System components include a needle and associated needle guide. They are intended to
®
System, the target anesthesia volume was 24 ml per handpiece usage.
®
System
®
treatment is at the discretion of the treating physician
User Manual
®
System
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