FDA inobvumira Restylane Defyne yekuwedzera shaya

Galderma akazivisa kuti FDA yabvumidza Restylane Defyne, HA dermal filler, yekuwedzera chirebvu.
Kambani yerunako nemishonga yeGalderma nguva pfupi yadarika yakazivisa kuti FDA yakabvumidza Restylane Defyne yekusimudzira nekugadzirisa kudzikira kwechirebvu zvakapfava kusvika pakati nepakati muvakuru vanopfuura makore makumi maviri nerimwe.
Restylane Defyne, yakatanga kutenderwa muna 2016, ndeye hyaluronic acid (HA) dermal filler yakatanga kushandiswa kwepakati kusvika kwakadzika jekiseni mumatishu echiso kurapa pakati nepakati kuunyana kumeso nekupeta.
Galderma inoshandisa iyo yakasarudzika nzira yekugadzira XpresHAN tekinoroji, inozivikanwa pasi rose seOptimal Balance Technology (OBT), kugadzira inotsvedzerera jekiseni jekiseni rinogona kusanganiswa nyore muganda rechisikigo uye rine simba kufamba.
"Izvi zvinoratidza nguva yechisere iyo Galderma yakagamuchira mvumo yeFDA mumakore mashanu, uye zvinoratidza kuti tine kuzvipira kwenguva refu kusimudzira aesthetics kuburikidza nehutsva hutsva," Alisa Lask, maneja mukuru uye mutevedzeri wemutungamiri weGalderma's American aesthetics bhizinesi, akadaro. mupepanhau rinozivisa kubvumirwa."Chirebvu ndiyo hwaro hwechiso uye inogona kudzikamisa humwe hunhu hwako.Vatengi zvino vanogona kushandisa zvisiri zvekuvhiya, sarudzo dzakachengeteka kugadzirisa matambudziko echirebvu.Iyo mhando inoshandisa yekucheka-kumucheto XpresHAN tekinoroji kuumba uye kuburitsa mhedzisiro inogara kwenguva refu. "
Mvumo yeRestylane Defyne yakawanikwa mushure me data kubva kune yakakosha Phase 3 kliniki yekuedza inotsigira kuchengetedzwa kwayo uye kushivirira mukuwedzera kweshaya.Pakati pevarwere vari muchidzidzo, 86% havana kuona zviitiko zvakashata zvine chokuita nekurapa, uye chiitiko chimwe chete chepakati chekurwadziwa kwejekiseni.
Zvikamu makumi mapfumbamwe nemapfumbamwe kubva muzana zvevarwere vakashuma kuvandudzwa kwechitarisiko chechirebvu chakabuda (payakabvunzwa pamasvondo gumi nemaviri), uye 96% yemajekiseni yakataura kuti kurapwa kwakavandudza kutaridzika kwechirebvu chakabuda kusvika gore.
Muedzo wacho wakaratidza kuti 74% yevarwere vakave nekuvandudzika kukuru mukufungidzira kwechirebvu kwenguva inosvika gore rimwe chete, zvichienzaniswa ne86% pamasvondo gumi nemaviri.Izvi zvinopimwa pachishandiswa Gartner's Chin Retraction Scale (GCRS).Mhedzisiro yeaesthetic mushure mekurapwa yaive yakanaka uye yakaratidzwa nehuwandu hwepamusoro hwekugutsikana kwechidzidzo muFACE-Q uye Global Aesthetic Improvement Scale (GAIS) mibvunzo.
“Varwere vangu vanowanzouya kwandiri kuzobvunza nezve nzira nyowani dzekurapwa kuti varambe vaine mamiriro avo akanaka.Vanhu vazhinji vanoshamisika pandinotsanangura mhedzisiro yeshaya yakakurisa uye kuenzana kwechiso chepasi ndiyo kiyi yekubatsira kukwezva kumeso kwakazara, "Anne Chapas, MD, chiremba-anocherechedzwa wedermatologist uye dermatologist muNew York, uye muongorori Restylane Defyne Chin kiriniki kuyedzwa, akadaro mukuburitswa kwenhau."Chikamu chepasi chechiso chinogara chiri kufamba, saka zvakakosha kuti varwere vasarudze mafirita ane simba akadai seRestylane Defyne, ayo akagadzirwa nesainzi kuti aenderane nezviso zvavo."