I-FDA ivuma unyango olutsha lwabantwana lwemeko yesingqi sentliziyo eqhelekileyo

I-Medtronic plc namhlanje ibhengeze ukuba iFreezor™ kunye neFreezor™ Xtra Cardiac Cryoablation Catheters zivunyiwe yi-US Food and Drug Administration (FDA) kwaye kuphela kweecatheter zokukhupha ezivunyiweyo ukunyanga ukuxhaphaka okukhulayo kweAtrioventricular Nodal Reentrant Tachycardia (AVNRT).  

I-AVNRT yeyona ndlela ixhaphakileyo ye-supraventricular tachycardia (SVT), kwaye isingqisho sentliziyo esisongela ubomi, kunye neemeko ezingama-89,000 ngonyaka kwaye zikhula. Phantse i-35% yeemeko ze-AVNRT zenzeka kwi-pediatrics, okanye, abantwana abangaphantsi kweminyaka eyi-18. Ngenxa yesiphaluka esingaqhelekanga ngaphakathi kwenkqubo yokuqhubela intliziyo, i-AVNRT ibangela isigqi senhliziyo esikhawuleza kakhulu, kwaye ukuba ingashiywa ingaphathwa, inokuchaphazela ukukwazi ukumpompa intliziyo. ngokuqhelekileyo, okukhokelela ekubetheleni kwentliziyo, ukuba nentloko ekhanyayo, kunye ne-syncope.

Ukukhutshwa kwecatheter lunyango lokuqala lonyango lwe-AVNRT. IiCatheters zeFreezor kunye neFreezor Xtra ziguquguqukayo, izixhobo ezisetyenziswa kanye kuphela ezisetyenziselwa ukukhenkceza izicubu zentliziyo kunye nokuthintela imiqondiso yombane engeyomfuneko ngaphakathi entliziyweni. Usapho lakwaFreezor lwenza ukuba unyango lwe-cryoablation olukhuselekileyo nolusebenzayo kwaye lunyange ngaphezu kwe-140,000 yezigulana kumazwe angama-67. I-Cryoablation inokunciphisa umngcipheko we-AV block esisigxina, ingxaki yeenkqubo ze-AVNRT ezenziwe nge-radiofrequency (RF) ablations ekhokelela ekuphazamisekeni okuyingxenye okanye okupheleleyo kweempawu zombane zentliziyo, eziphazamisa ngokuyingozi isigqi sentliziyo.

"Zimbalwa kakhulu izixhobo ezivunyiweyo ukunyanga izigulana zentliziyo zabantwana namhlanje," utshilo uBryan C. Cannon, MD, unjingalwazi wezifo zabantwana kunye nomongameli odlulileyo we-Pediatric & Congenital Electrophysiology Society (PACES), umbutho omkhulu kwihlabathi labantwana. isingqi esikhethekileyo oogqirha. “Ngokwandiswa kwesalathiso se-FDA, iFreezor kunye neFreezor Xtra cardiac cryoablation catheters ivumela kwanabona bancinci kwizigulana zentliziyo ukuba bafikelele kukhuseleko, itekhnoloji yokuphucula ubomi eya kunceda ukuqhubela phambili ukhathalelo lwentliziyo lwe-AVNRT.”

Ukwamkelwa kokwandiswa kwesibonakaliso kuxhaswa ziziphumo ezivela kwi-ICY-AVNRT kunye nezifundo zabantwana ezininzi ezingahleliwe, zamaziko amaninzi abonise ukhuseleko kunye nokusebenza kakuhle kwonyango lwe-AVNRT usebenzisa i-Freezor kunye ne-Freezor Xtra ye-cardiac cryoablation catheters. Idatha ye-ICY-AVNRT ibike ukuphumelela kwenkqubo ye-95% ngaphandle kweengxelo ze-pacemaker esisigxina ngenxa yokugqiba i-AV block.1 Ubungqina obuninzi bobungqina, kubandakanywa nezifundo ezilishumi elinesithandathu, nazo zabona izinga eliphezulu lokusebenza kunye neziganeko ezimbi eziphantsi.2-17

I-Freezor cardiac cryoablation catheter yaqala ukufumaneka ngezorhwebo e-US ukusetyenziswa kwabantu abadala kwe-AVNRT kwi-2003, ilandelwa yi-Freezor Xtra cardiac cryoablation catheter ngo-2016. Intsapho yaseFreezor ye-cryoablation catheters iquka i-Freezor MAX ye-cardiac cryoablation, evunyiweyo kwi-catheter ye-cardiac, isetyenziswe ngokubambisana ne-Arctic Front™ Advance cryoballoon kunyango lwe-atrial fibrillation (AF).

“Siyazingca ngomsebenzi wethu nePACES kunye ne-FDA kweli nyathelo lokuqala lohlobo lwayo, inyathelo labathathi-nxaxheba abaninzi lokujongana nezigulana eziyingozi,” utshilo uRebecca Seidel, umongameli weshishini leCardiac Ablation Solutions, eliyinxalenye iCardiovascular Portfolio e-Medtronic. "Ukuzinikela ekwabelwana ngako ekusebenzisaneni kunye nokukhulisa indawo eyodwa yolu nyango lokunyanga izigulane ze-AVNRT kubonisa ukuzithemba kwethu kukhuseleko oluqinisekisiweyo kunye nokusebenza kakuhle kobuchwepheshe bethu be-cryoablation."

I-Medtronic iye yaphayona iteknoloji ye-cryoablation, enobungqina obuphambili kunye nobungqina obuninzi, kubandakanywa ukhuseleko oluqinisekisiweyo kunye nokusebenza kakuhle ekuphatheni i-AF kunye ne-AVNRT. Ukuza kuthi ga ngoku, bangaphezulu kwesigidi abaguli abanyangwe ngonyango lwe-Medtronic cryoablation kwihlabathi jikelele.

Ngentsebenziswano noogqirha abakhokelayo, abaphandi, kunye nososayensi kwihlabathi liphela, iMedtronic ibonelela ngoluhlu olubanzi lwetekhnoloji yonyango yongenelelo kunye nonyango lotyando lwesifo sentliziyo kunye ne-arrhythmias yentliziyo. Inkampani izama ukubonelela ngeemveliso kunye neenkonzo ezikumgangatho ophezulu ohambisa ixabiso leklinikhi kunye nezoqoqosho kubathengi kunye nababoneleli bezempilo emhlabeni jikelele.