I-FDA igunyaza ukwelashwa kwezingane okusha kwesigqi esivamile senhliziyo

I-Medtronic plc namuhla imemezele ukuthi iFreezor™ kanye neFreezor™ Xtra Cardiac Cryoablation Catheters zigunyazwe yi-US Food and Drug Administration (FDA) futhi ukuphela kwama-catheter ablation agunyazwe ukwelapha ukusabalala okukhulayo kwe-Atrioventricular Nodal Reentrant Tachycardia (AVNRT) yezingane.  

I-AVNRT iwuhlobo olujwayeleke kakhulu lwe-supraventricular tachycardia (SVT), futhi iyisigqi senhliziyo esisongela ukuphila, esinamakesi angu-89,000 unyaka ngamunye futhi siyakhula. Cishe u-35% wezigameko ze-AVNRT zenzeka ku-pediatrics, noma, izingane ezineminyaka engaphansi kwe-18. Ngenxa yokujikeleza okungavamile ngaphakathi kwesistimu yokusebenza kwenhliziyo, i-AVNRT ibangela isigqi senhliziyo esisheshayo, futhi uma ingelashwa, ingathinta ikhono lenhliziyo lokupompa. ngokuvamile, okuholela ekushayeni kwenhliziyo, ukuba nekhanda elilula, kanye ne-syncope.

I-Catheter ablation iwumugqa wokuqala wokwelapha we-AVNRT. Ama-Freezor Xtra Catheter ayasebenziseka kalula, asetshenziswa kanye kanye asetshenziselwa ukumisa izicubu zenhliziyo futhi avimbe amasignali kagesi angadingekile ngaphakathi kwenhliziyo. Umndeni wakwaFreezor unika amandla ukwelashwa kwe-cryoablation okugxile okuphephile futhi okusebenzayo futhi welapha iziguli ezingaphezu kwezi-140,000 emazweni angama-67. I-cryoablation inganciphisa ingozi ye-AV block unomphela, inkimbinkimbi yezinqubo ze-AVNRT ezenziwa nge-radiofrequency (RF) ablations ephumela ekuphazamisekeni okuyingxenye noma okuphelele kwamasignali kagesi wenhliziyo, okuphazamisa ngokuyingozi isigqi senhliziyo.

"Kunemishini embalwa kakhulu egunyazwe ukwelapha iziguli zenhliziyo eziyinkimbinkimbi ngokwezokwelapha zezingane namuhla," kusho uBryan C. Cannon, MD, uprofesa wezifo zezingane kanye nomongameli odlule we-Pediatric & Congenital Electrophysiology Society (PACES), inhlangano enkulu kunazo zonke emhlabeni yezingane. odokotela abakhethekile ngesigqi. “Ngokunwetshwa kwenkomba ye-FDA, ama-catheter e-Freezor kanye ne-Freezor Xtra cardiac cryoablation avumela ngisho neziguli ezincane kakhulu zenhliziyo ukuthi zifinyelele kubuchwepheshe obuphephile, obuthuthukisa ukuphila obuzosiza ukuthuthukisa ukunakekelwa kwenhliziyo kwe-AVNRT.”

Ukugunyazwa kwenkomba kusekelwa imiphumela evela ku-ICY-AVNRT kanye nezifundo eziningi zezingane ezingahleliwe, ezimaphakathi eziningi ezibonise ukuphepha nokusebenza ngempumelelo kokwelashwa kwe-AVNRT kusetshenziswa ama-catheter e-Freezor ne-Freezor Xtra e-cardiac cryoablation. Idatha ye-ICY-AVNRT ibike impumelelo eqinile yenqubo ye-95% ngaphandle kwemibiko ye-pacemaker unomphela ngenxa ye-AV block ephelele.1 Ubufakazi obuningi, kuhlanganise nenani lezifundo eziyishumi nesithupha, futhi labona amazinga aphezulu okusebenza kanye nezenzakalo ezimbi eziphansi.2-17

I-Freezor cardiac cryoablation catheter yaqala ukutholakala ngezohwebo e-US ukuze isetshenziswe abantu abadala i-AVNRT ngo-2003, yalandelwa yi-Freezor Xtra cardiac cryoablation catheter ngo-2016. Umndeni wakwaFreezor wama-cryoablation catheter uhlanganisa ne-Freezor MAX cardiac cryoablation egunyazwe i-cater yenhliziyo, sebenzisa ngokuhlanganyela ne-Arctic Front™ Advance cryoballoon yokwelapha i-atrial fibrillation (AF).

"Siyaziqhenya ngomsebenzi wethu ne-PACES kanye ne-FDA kulolu hlelo lokuqala lwalo, olubandakanya ababambiqhaza abaningi lokubhekana neziguli ezibucayi," kusho uRebecca Seidel, umongameli webhizinisi le-Cardiac Ablation Solutions, eliyingxenye ye-Cardiac Ablation Solutions. Iphothifoliyo yeCardiovascular at Medtronic. “Ukuzinikela okwabiwe ngokubambisana nokukhulisa lesi simo esiyingqayizivele salokhu kwelashwa ekwelapheni iziguli ze-AVNRT kukhombisa ukwethemba kwethu ukuphepha okuqinisekisiwe nokusebenza ngempumelelo kobuchwepheshe bethu be-cryoablation.”

I-Medtronic isungule ubuchwepheshe be-cryoablation, enobufakazi obuhamba phambili embonini nobubanzi obuningi, okuhlanganisa ukuphepha okuqinisekisiwe nokusebenza ngempumelelo ekwelapheni i-AF ne-AVNRT. Kuze kube manje, iziguli ezingaphezu kwesigidi sezelashwe nge-Medtronic cryoablation therapy emhlabeni wonke.

Ngokubambisana nodokotela abaholayo, abacwaningi, nososayensi emhlabeni wonke, i-Medtronic inikeza uhla olubanzi kakhulu lobuchwepheshe bezokwelapha obusha bokwelapha okungenelele nokuhlinzwa kwesifo senhliziyo nemithambo yegazi kanye ne-arrhythmias yenhliziyo. Inkampani ilwela ukunikeza ngemikhiqizo namasevisi eqophelo eliphezulu kakhulu eliletha inani lomtholampilo nezomnotho kubathengi nabahlinzeki bezempilo emhlabeni wonke.