NgoJanuwari 14, 2015, i-US Food and Drug Administration (i-FDA) ivume idivayisi yokuqala yezokwelapha yokwelapha ukukhuluphala. Le divayisi, eyaziwa ngokuthi i-Maestro Rechargeable System, ivunyiwe ukuze isetshenziswe kubantu abadala abathile abakhuluphele. Leli yilapho yezokwelapha yokuqala okufanele yamukelwe yi-FDA yokwelashwa kokukhuluphala kusukela ngo-2007.
Njengoba kunikezwa ukuthi, ngokusho kwamaCenters for Disease Control and Prevention (CDC), ingxenye eyodwa kwezintathu kubo bonke abantu base-US abakhuluphele, ukufika kwedivaysi yezokwelapha entsha yokwelashwa yizindaba ezitholela ukunakwa okukhulu.
Isebenza kanjani?
Uhlelo lwe-Maestro Lokulungiswa Kokusebenza lusebenza ngokuqondisa indlela yomzila phakathi kobuchopho nesisu esisenza ukulawula phezu kwemizwa yindlala nokugcwala. Iqukethe i-generator ye-pulse generator ephindwe kabusha, kanye nomthofu wocingo nama-electrode. Lezi zifakiwe zihlinzekwe ngokuhlinzwa ngaphakathi kwesisu. I-ke ithumela imishanguzo kagesi ku-vagus nerve, esiza ukulawula isisu ekuthumeni futhi ithumele isignali ebuchosheni ukuthi isisu mhlawumbe uzizwa singenalutho noma ugcwele.
Ngokusho kwe-EnteroMedics Inc., inkampani eyenza ukuthi idivaysi, uhlelo lwe-Maestro Rechargeable System luvimbele amasignali ukuthi i-vagus nererve ingayithumela ebuchosheni, ngaleyo ndlela ukunciphisa imizwa yendlala nokwenza iziguli zizwe ziphelile kunokuba zingenjalo.
Inhloso Yani?
Ngokusho kwe-FDA, le divaysi yezokwelapha ivunyelwe abantu abadala (abaneminyaka engama-18 nangaphezulu) abane-mass mass Index (BMI) yama-35 kuya ku-45, okungenani isimo esisodwa sezokwelapha ezihlobene nokukhuluphala, njengesifo sikashukela sesibili noma sokuvimbela i-apnea yokulala .I - FDA ichaze ukuthi lezi ziguli kufanele zibonise okokuqala ukuthi azikwazanga ukulahlekelwa isisindo ngehlelo lokulahlekelwa isisindo.
Iphumelela Kangakanani?
Esinye isilingo somtholampilo esibandakanya iziguli ezine-BMI ezineminyaka engama-35 noma ngaphezulu, labo abasesigabeni sokuhlola (abathola idivayisi esebenzayo ye-Maestro) babona imiphumela ephawulekayo yokulahlekelwa kwemiphumela: cishe isigamu sabo balahlekelwa okungenani amaphesenti angu-20 esisindo sabo ngokweqile, futhi Amaphesenti angu-38 awo alahlekelwa okungenani ama-25% esisindo saso ngokweqile.
Yiziphi Izingozi Zangase Zenzeke?
Imiphumela emibi ebikwe esilingo semitholampilo lapho kuvunyelwe khona ukufaka isicelo: i-nausea, ukuhlanza, ubuhlungu endaweni yokufakelwa kokuhlinzwa, izinkinga zokuhlinzwa, ukushaya isisu, ubuhlungu besifuba, ubunzima bokugwinya nokugubha. Njenganoma yikuphi ukuhlinzwa okusebenzayo noma inqubo, kungaba khona izinkinga, njengokutheleleka nokuphuma kwegazi, okubangelwa yinqubo ngokwayo.
I-FDA ibike ukuthi, njengengxenye yokuvunywa, i-EnteroMedics kumele iqhube isifundo se-post-approval approved iminyaka emihlanu esilandelayo okungenani iziguli ezingu-100 iminyaka emihlanu bese iqoqa ulwazi olwengeziwe ngokuphepha nokusebenza kwedivayisi.
Ukudla okunempilo nokuzivocavoca kusadingeka
Ngokuqinisekile le divayisi ayikuqedi isidingo sokuqhubeka nokudla okunempilo okuncane kokudla okucutshungulwayo kanye nezithelo nemifino ephezulu. Futhi akuqedi isidingo esibucayi sokuhlala sisebenza ngokomzimba nsuku zonke .
Zombili lezi zindlela zezempilo zibalulekile hhayi kuphela ekulahlekelweni kwesisindo, kodwa ekuvimbeleni zonke izinhlobo zezifo ezingapheliyo, kufaka phakathi isifo senhliziyo, isifo sohudo, isifo sikashukela, umdlavuza, kanye nesifo sengqondo somqondo.
Imithombo :
I-FDA. Ukukhululwa kwezindaba: I-FDA ivumela idivayisi yokuqala yokuphatha ukukhuluphala ngokweqile. Kufinyelelwe ku-intanethi ku- http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430223.htm ngoJanuwari 16, 2015.