NgoJanuwari 14, 2015, i-US Food and Drug Administration (i-FDA) yaseMelika ivume idilesi yokuqala yonyango yayo yokwenza unyameko. Le fowuni, eyaziwa ngokuba yi-Maestro Rechargeable System, iye yavunywa ukuba isebenzise kubantu abadala abathile. Le yicandelo lokuqala lezokwelapha eliza kuvunywa yi-FDA kunyango lokunyanyisa ukususela ngo-2007.
Ngenxa yokuba, ngokweZiko loLawulo lokuLawula nokuVimbela (i-CDC), enye yesithathu kubo bonke abantu base-US baninzi, ukufika kwesicwangciso seyeza olutsha kunyango oluye lugqithise kakhulu ingqalelo.
Ingaba isebenza kanjani?
I-Maestro I-Recestableable System isebenza ngokujolisa kwindlela yokugulisa intliziyo phakathi kwengqondo kunye nesisu esinolawulo lokuvalelwa kwindlala nokuzaliswa. Iqukethe i-generator pulse generator ehlawulelwayo, kunye neendlela zetambo kunye ne-electrodes. Ezi zifakwe kwi-abdomen. Emva koko ithumela iimpembelelo zombane kwi-vagus nerve, eyanceda ukulawula isisu sokuthutha nokuthumela iimpawu kwiingqondo ukuba isisu sisenokungananto okanye sigcwele.
Ngokutsho kwe-EnteroMedics Inc., inkampani eyenza idivayisi, i-Maestro Rechargeable System ikhusela iimpawu zokuthi i-nerus vagus yayiya kubathumela kwingqondo, ngaloo ndlela iyanciphisa iimvakalelo zendlala kwaye yenza izigulane zizive ziphelile kunokuba zingenjalo.
Ubani Ubutyebi?
Ngokutsho kwe-FDA, esi sixhobo sonyango siye savunywa kubantu abadala (abaneminyaka engama-18 nangaphezulu) abanesigxina se-body mass (BMI) se-35 ukuya ku-45, ubuncinane kunye nesimo sengonyango esinxulumene nokukhuluphala, njengesifo sikashukela okanye isithintelo i-apnea yokulala .I-FDA ichaze ukuba ezi zi gulane zimele zibonise okokuqala ukuba azizange zikwazi ukunciphisa ubunzima ngokusebenzisa inkqubo yokulahlekelwa kwesisindo.
Usebenza Njani?
Kwilingo linye lonyango elabandakanya izigulane ezine-BMI ezingama-35 okanye ngaphezulu, abo beqela lezilingo (abafumana i-device ye-Maestro esebenzayo) babone iziphumo ezibalulekileyo zokulahlekelwa ngumlinganiselo: malunga nesiqingatha sazo salahlekelwa ubuncinane ubuncinane be-20 ekhulwini zexabiso, I-38% yazo yalahlekelwa ubuncinane ngama-25% obunzima bobunzima.
Ziziphi Iimpembelelo Zangaphandle?
Imiphumo emibi echazwe kwilingo lekliniki apho kuvunyelwe ukuvunywa kwakubandakanya: isicupunu, ukuhlanza, intlungu kwisayithi yokufakelwa kwezicwangco, iingxaki zokugonywa, ukugubha intliziyo, intlungu yesifuba, ubunzima bokugwinya kunye nokubetha. Njengoko naluphina utyando okanye inkqubo, kukho iingxaki, ezifana nokusuleleka kunye nokuphuma kwegazi, okubangelwa yinkqubo ngokwayo.
I-FDA ibonile ukuba, njengenxalenye yokuvunywa, i-EnteroMedics kufuneka iqhube isifundo seminyaka emihlanu yokuvunywa emva kokuvunywa esilandela ubuncinane iigulane ezingama-100 kwiminyaka emihlanu kwaye iqokelela ulwazi olongezelelweyo ngokukhuselekileyo nokusebenza kwesixhobo.
Ukutya okunokulinganisela kunye nokuzivocavoca kuyafuneka
Ngokuqinisekileyo esi sixhobo asiyikuphelisa isidingo sokuqwalasela okuqhubekayo ekudleni okunesondlo ephantsi kokutya okucutshulweyo kunye nezityalo kunye nemifuno ephezulu. Akunakukuphelisa imfuno ebalulekileyo yokuhlala emzimbeni kwansuku zonke .
Zomibini lezi nyathelo zempilo zibalulekile kungekhona nje ukulahleka kwesisindo, kodwa ukukhusela zonke izifo ezingapheliyo, kuquka isifo senhliziyo, isifo, isifo sikashukela, umhlaza, kunye nomqondo wokugula komzimba.
Imithombo :
FDA. Ukukhululwa kweendaba: I-FDA iyavuma idivaysi yokuqala yokwenza unyamebe. Ifumaneka kwi-Intanethi kwi-http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430223.htm ngoJanuwari 16, 2015.