Cellfina Trattamento definitivo della cellulite
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.
Dettagli del trattamento
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.
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
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.
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.
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.
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.
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.