FDA Ivomereza Pulogalamu ya EVO Visian® ICL, Tsopano Yafika ku Utah

Ngati mwatopa ndi matenda a myopia ndi kukhudzana pafupipafupi kapena kukhudzana ndi magalasi, EVO Visian ICL™ (STAAR® Surgical Phakic ICL ya Myopia ndi Astigmatism) ikhoza kukhala zomwe mwakhala mukuyembekezera, ndipo patatha zaka zopitirira makumi awiri kuchokera kunja. US, ikupezeka ku Utah ku Hoopes Vision.
Pa Marichi 28, 2022, kampani ya STAAR Surgical Company, yomwe ikutsogolera kupanga magalasi oyika, idalengeza m'manyuzipepala kuti US Food and Drug Administration (FDA) idavomereza EVO/EVO+ Visian® Implantable Collamer® Lens (EVO) ngati Myopia yotetezeka. ndi komanso popanda astigmatism komanso mankhwala othandiza ku US
"Ma lens oposa 1 miliyoni a EVO adayikidwa ndi madokotala kunja kwa US, ndipo 99.4% ya odwala EVO mu kafukufuku adanena kuti adzachitidwanso opaleshoni," anatero Caren Mason, pulezidenti ndi CEO wa STAAR Surgical.
"Kugulitsa magalasi a EVO kunja kwa US kudakwera 51% mu 2021, kuwirikiza kawiri kuyambira 2018, kuwonetsa kusankha kwa odwala ndi anzathu ochita opaleshoni a EVO ngati njira yabwino kwambiri yowongolera zowongolera ndi mayankho akulu."

Lumikizanani ndi Chida Chochotsa Lens

Lumikizanani ndi Chida Chochotsa Lens
Njira yowongolera masomphenya a tsiku lomwelo imatha kutha pafupifupi mphindi 20-30. Sikuti njirayo imakhala yofulumira komanso yopanda ululu, EVO ICL ili ndi mwayi wopeza nthawi yochira mwachangu, palibe chifukwa cholumikizira magalasi ndi magalasi, komanso kuwongolera. Kuwona mtunda ndi usiku pafupifupi usiku wonse - kwa anthu ambiri okhumudwa ndi ma lens kapena magalasi, Maloto amakwaniritsidwa.
Myopia, yomwe imadziwikanso kuti "kuyang'ana pafupi," ndi imodzi mwazochitika zofala kwambiri padziko lonse lapansi, pamene munthu amatha kuona zinthu zapafupi, koma zinthu zomwe zili kutali zimawoneka ngati zosawoneka bwino. kufalikira kwa myopia kukuchulukirachulukira ku United States komanso padziko lonse lapansi, ndipo ofufuza akuyembekeza kuti izi zipitilira kwazaka zambiri zikubwerazi.
Myopia imachitika pamene maso a munthu amakula motalika kwambiri kuchokera kutsogolo kupita kumbuyo, kuchititsa kuwala kutembenuka kapena "kupindika" molakwika. Pafupifupi 41.6 peresenti ya anthu a ku America sawona pafupi, "kuchokera pa 25 peresenti mu 1971," lipoti la NEI linatero.
Opaleshoni ya STAAR ikuyerekeza kuti akulu akulu aku US 100 miliyoni azaka zapakati pa 21 ndi 45 atha kukhala ofuna EVO, lens lololedwa bwino lomwe limawongolera kuwona kwakutali kwa munthu, kuwalola kuwona zinthu zakutali.
Ma lens a EVO Visian amadziwikanso kuti "Implantable Collamer® Lens" .Malensi amapangidwa ndi zinthu za STAAR Surgical's proprietary Collamer.Zimakhala ndi kolajeni yoyeretsedwa pang'ono ndipo zotsalazo zimapangidwa ndi zinthu zofanana zomwe zimapezeka m'magalasi ofewa.Collamer ndi yofewa. , khola, flexible and biocompatible.Collamer ali ndi mbiri ya ntchito bwino intraocular padziko lonse ndipo zatsimikizira kuti ndi omasuka ndi ogwira ophthalmic mandala zinthu.
Pamaso pa opaleshoni ya EVO Visian ICL, dokotala wanu adzachita mayesero angapo kuti ayese mikhalidwe yapadera ya diso lanu.Mwamsanga musanachite opaleshoni, dokotala wanu adzagwiritsa ntchito madontho a maso kuti achepetse ana anu ndikugwedeza maso anu.Kenako, lens ya EVO ICL idzakhala pindanidwa ndi kulowetsa mu kabowo kakang'ono m'mbali mwa cornea.

Lumikizanani ndi Chida Chochotsa Lens

Lumikizanani ndi Chida Chochotsa Lens
Pambuyo poika lens, dokotala adzakonza zofunikira zonse kuti atsimikizire malo olondola a lens.Lens idzayikidwa mwamphamvu kumbuyo kwa iris (gawo lakuda la diso) ndi kutsogolo kwa lens lachilengedwe. atayikidwa, inu ndi ena simungachiwone, ndipo lens yofewa, yosinthasintha imagwirizana bwino ndi diso lanu lachilengedwe.
Kwa zaka zopitilira 20, magalasi a Collamer opangidwa ndi STAAR akhala akuthandizira odwala kuti azitha kuwona bwino, kuwamasula ku magalasi ndi magalasi olumikizirana, ndipo pomaliza, EVO ICL idalandira chilolezo cha FDA kwa odwala aku US.
"Ndife okondwa kupereka EVO kwa madokotala ochita opaleshoni a US ndi odwala omwe akufuna njira yotsimikiziridwa ya magalasi apamwamba kwambiri, ma lens, kapena laser vision correction," anatero Scott D. Barnes, MD, Chief Medical Officer wa STAAR Surgical."Kulengeza kwamasiku ano ndikofunikira kwambiri, Chifukwa kuchuluka kwa myopia kukuchulukirachulukira, njira zodzitetezera ku COVID zimabweretsa zovuta zina kwa iwo omwe amavala magalasi ndi/kapena magalasi olumikizirana.
"EVO imawonjezera chida chofunikira kwa ophthalmologists omwe akufuna kuthandiza kusintha moyo wa wodwala.Mosiyana ndi LASIK, ma lens a EVO amawonjezedwa m'diso la wodwala kudzera mu opaleshoni yofulumira, popanda kufunikira kochotsa minofu ya cornea.Kuphatikiza apo, ngati angafune, madokotala amatha kuchotsedwa ma lens a EVO.Zotsatira za mayeso athu aposachedwa azachipatala ku US zikugwirizana ndi magalasi a EVO opitilira miliyoni imodzi omwe adayikidwa padziko lonse lapansi. "
EVO ndi njira yothetsera masomphenya yovomerezeka ndi FDA kwa odwala myopic kapena opanda astigmatism omwe akufuna kuthetsa kufunikira kwa magalasi kapena ma lens. zikutheka kuti EVO si yoyenera kwa omwe adakumana ndi LASIK, chifukwa ndondomekoyi sinakhazikitsidwe ngati njira yotetezeka kwa odwala omwe ali ndi mbiri ya matenda a maso .
Kodi mwakonzeka kukhala ndi moyo wathunthu? Kuti mudziwe ngati pulogalamu ya EVO ICL ndi yoyenera kwa inu, chonde lemberani Hoopes Vision kuti mukonzekere zokambirana zanu za VIP. Ku Hoopes Vision, odwala amasangalala ndi mbiri yabwino kwambiri yachitetezo ndi zotsatira zotsimikiziridwa, kwinaku akuyamikira momwe amachitira. yesetsani kuchita zonse zomwe angathe kuti kuwongolera bwino kwa masomphenya kukhale kotsika mtengo komanso kotheka kwa odwala omwe ali ndi bajeti zosiyanasiyana.


Nthawi yotumiza: May-21-2022