Medtronic Heart Valve Inoderedza Kurohwa Uye Kufa Kwekufa
Medtronic Heart Valve Inoderedza Kurohwa Uye Kufa Kwekufa
Anonim

Medtronic, Inc. yakapa data nhasi ichiratidza CoreValve heart valve implant yakaderedza rufu uye sitiroko mazinga muvarwere vane ngozi yakawanda vairapwa kuburikidza ne subclavian uye yakananga aortic (isina-ililifemoral) nzira dzekusvika. Iyo CoreValve System haisati yatenderwa kushandiswa kwekutengeserana muU.S., kunyange yakasimwa mune vanopfuura 45, 000 varwere munyika yose kubvira 2007. Nhasi, kambani yakazivisa dheta rayo kubva kune imwe nguva yekliniki yekuedza.

"Izvi zvigumisiro zvinoratidza nzira isiri-iliofemoral isarudzo inoshanda kune varwere vane aortic stenosis yakaoma avo vasiri kugadzirira kuvhiyiwa kana kuti transcatheter valve replacement kuburikidza netsika yeperipheral access," David H. Adams, MD, sachigaro weDhipatimendi reCardiothoracic Surgery at Gomo reSinai Medical Center, mukuru-mukuru-mukuru wekuongorora weCoreValve US Pivotal Trial, akadaro mukuburitswa kwenhau.

Aortic Stenosis

Kana iyo aortic valve isingavhurike zvizere, mamiriro anonzi 'aortic stenosis,' kubuda kweropa kubva pamoyo kunoderera. Haisi mamiriro akajairika, kunyangwe inobata vanhu vangangoita mazana matatu ezviuru pasi rese uye inowanzoitika muvarume pane vakadzi. Aortic stenosis inowanzokonzerwa ne calcium deposits iyo inoderedza valve, inozivikanwa se calcific aortic stenosis, asi inogonawo kukonzerwa ne rheumatic fever, iyo iyo dambudziko revhavha rinogona kusakura kwemakore mashanu kusvika ku10.

Gore roga roga, vanhu vanoda kusvika 200,000 pasi rose vanogamuchira mavharuvhu ekuvhiya aortic. Kunyange zvazvo izvi zvinowanzogara makore 15 kana kupfuura, mavharuvhu anoderera nekuda kwekukwegura uye varwere vanoda imwe. Asi, varwere vakadaro vanowanzochembera uye vasina simba zvokukwanisa kutsungirira kumwe kuvhiyiwa. Muchokwadi, yevarwere vanotambura neaortic stenosis yakaoma, chikamu chimwe muzvitatu hachikodzeri kuvhiyiwa kwemoyo wakavhurika nekuti vanoonekwa vari panjodzi yakanyanya. Iyo CoreValve System, kunyange zvakadaro, inogona kupa sarudzo nyowani nekuti iyo yega-yegavhavhavha inoiswa mukati meiyo yakadzikira yekuvhiya aortic valve kuburikidza nevhavha-mu-vharuvhu maitiro. Maitiro acho anosanganisira kuendesa iyo implant uchishandisa catheter inosvika nenzira dzakasiyana, ingave iri munzira yetransfemoral, subclavian, kana yakananga aortic yekupinda nzira.

"Iyi nzira inobvumira varwere kuti vadzivise kuvhiyiwa kwechipiri kwemwoyo wakazaruka kuti vatsive vheji yekuvhiya yakakundikana, iyo yakatanga kuitwa kuti itsive yavo yevhavha yechirwere." John Liddicoat, MD, mutungamiri weMedtronic Structural Heart Business, akadaro mukuburitswa kwenhau.

KuChidzidzo cheNjodzi Yakanyanya, varwere 146, vaifunga kurwara zvakanyanya kana kuti vasina simba kuti vatsive mavharuvhu avo kuburikidza nekuvhiyiwa kwemoyo kwakavhurika, vakarapwa neimwe nzira yekuwana. Kuburikidza negore rimwe chete, varwere ava vakaratidza mazinga akakwirira ekubudirira kwemaitiro uye kushanda kwevhavha, nekurohwa kukuru kwe6.3 muzana pamwedzi mumwe. MuCoreValve Kuenderera mberi Kuwana Chidzidzo, kumwe kunowanikwa varwere vaive nechiyero chikuru che2.3 muzana pamwedzi mumwe. Kakawanda, data yakaratidza chiyero chekufa kana chirwere chikuru chaiva 25.5 muzana kune varwere vanobatwa nevhavha.

Medtronic, iyo yakapa mhedzisiro iyi pamusangano weTranscatheter Cardiovascular Therapeutics, inotarisira kutsvaga mvumo yechigadzirwa kubva kuU.S. Food and Drug Administration. Inotungamirwa muMinneapolis, kambani inopa tekinoroji yekurapa yekupindira uye yekuvhiya kurapwa kwechirwere chemoyo uye cardiac arrhythmias.

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