Cellfina Trattamento definitivo della cellulite

Cellfina™ è un trattamento efficace per trattare la famosa buccia d’arancia ed è molto semplice nella sua esecuzione. Individuata la parte da trattare si applica il dispositivo che sollevando la pelle attraverso una delicata aspirazione permette ad un sottile aghetto l’inoculazione dell’anestetico. A questo punto, mediante l’azionamento di un altro ago ha inizio il vero e proprio trattamento che permette la recisione delle fibre connettive responsabili dell’effetto “buccia d’arancia”.

Il trattamento si svolge in circa 45 minuti, anche se la durata dipende dal numero e dalla vastità delle aree su cui intervenire.

Il trattamento è ambulatoriale in anestesia locale ed è ben tollerato dalla maggior parte dei pazienti. Ne segue solo un leggero indolenzimento. La ripresa al sociale è immediata, rimarranno dei piccoli ematomi che tendono a scomparire nei giorni successivi. E’ un trattamento adatto a tutti ed è efficace anche come terapia di mantenimento per pazienti post liposuzione.

E’ importante sottolineare che Cellfina™ è un dispositivo approvato dalla FDA, l’ente governativo statunitense che si occupa della regolamentazione dei prodotti alimentari e farmaceutici dalla FDA e che certifica che Cellfina è l’unico sistema certificato per effetti che durano due anni.

eliminare-cellulite-cellfina

Dettagli del trattamento
Anestesia: locale
Tempo di trattamento: 45 minuti (dipende dall’area da trattare)
Livello del dolore: leggero
Efficace per 2 anni

Il trattamento prevede l’uso di un dispositivo dotato di una sorta di oblò che viene applicato sulla parte da trattare e pratica una piccola aspirazione, sollevando di qualche millimetro i tessuti. Attraverso le guide di cui il dispositivo è fornito, viene poi inserito un sottile ago che diffonde l’anestesia locale nei tessuti da trattare. Non appena questa ha fatto effetto, viene introdotto e azionato un ago di diametro maggiore, che recide le fibre connettive retraenti presenti tra i tessuti sclerotizzati e il grasso.

cellfina

Studi scientifici su Cellfina

Multicenter Pivotal Study of the Safety and Effectiveness of a Tissue Stabilized-Guided Subcision Procedure for the Treatment of Cellulite: 3 Year Update
Michael S. Kaminer, MD; Deanne M. Robinson, MD; William P. Coleman III, MD; Robert A. Weiss, MD; W. Patrick Coleman IV, MD
Background
Tissue release (subcision) for cellulite has been practiced for decades with limited success. The purpose of this study was to determine the safety and efficacy of a new tissue stabilized-guided subcision (TS-GS) system for the treatment of cellulite.
Design
Pivotal prospective multi-centered safety and effectiveness study (n=55). Subjects served as own controls, underwent a single treatment and followed out to 3 years. Safety and effectiveness were evaluated by blinded, independent physician using (before/after) photographs and a validated 5 point severity scale.
Results
Treatments were well tolerated with minor expected effects that resolved quickly. Improvement was rapid and pronounced. 45 subjects completed 3 year follow-ups with average reduction in cellulite severity: 2.0 points (p<0.0001), masked evaluator improvement: 97%, evaluators rated 100% of subjects as having noticeable improvement and 93% of subjects were satisfied or very satisfied.
Summary
A single treatment with a novel TS-GS release system improved the appearance of cellulite on
the thighs and buttocks through 3 years with minimal adverse effects. Study supported the FDA- clearance of the device as an effective and safe treatment for long-term improvement in the appearance of cellulite of the buttocks and thighs with no diminishment of benefit for up to 2 years.
Objectives:
1. Understand the MOA of a new tissue stabilized-guided subcision (TS-GS) system FDA cleared for the long-term treatment of cellulite.
2. Understand the efficacy and safety profile of the new TS-GS system.

Multicenter Pivotal Study of the Safety and Effectiveness of a New Tissue Stabilization and Targeted Release Procedure for the Treatment of Cellulite – 2 Year Update
Michael S. Kaminer, MD, Skincare Physicians, Chestnut Hill, MA, United States; William P. Coleman III, MD, Coleman Cosmetic and Dermatologic Surgery Center, Metairie, LA, United States; Robert A. Weiss, MD, Maryland Laser Skin and Vein Institute, Hunt Valley, MD, United States; Deanne M. Robinson MD, Skincare Physicians, Chestnut Hill, MA, United States; W. Patrick Coleman IV, MD, Coleman Cosmetic and Dermatologic Surgery Center, Metairie, LA, United States.
Tissue release for cellulite has been practiced for decades with limited success. A novel procedure has been developed which stretches and stabilizes tissue while providing integrated anesthesia delivery and precise depth control of minimally-invasive subcutaneous release.
A FDA approved, prospective safety and effectiveness study was conducted in 3 US centers enrolling 55 subjects. Subjects served as their own controls, underwent a single treatment and were followed at regular intervals out to 2 years. Safety was assessed by an independent Data Safety Monitoring Board. Effectiveness was evaluated by blinded, independent physician evaluators using randomized (before/after) professional photographs and a novel, validated 5 point severity scale.
Treatments were well tolerated with minor expected effects. Improvement was rapid and pronounced. 52 subjects completed 2 year follow-ups. 2 year average reduction in cellulite severity was 2.0 points (p<0.0001) and masked evaluator improvement was 98%. Evaluators rated 100% of subjects as having noticeable improvement and 96% of subjects were either satisfied or very satisfied.
Controlled release of tissue under tension at precise depths leads to significant, lasting improvement in cellulite, a dermatologic disorder with significant social stigma and adverse effects on self-esteem.

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