FDA imavomereza chithandizo chamankhwala chatsopano cha ana omwe ali ndi vuto la mtima wofanana

Medtronic plc lero yalengeza kuti ma Catheters a Freezor™ ndi Freezor™ Xtra Cardiac Cryoablation Catheters ndi ovomerezeka ndi US Food and Drug Administration (FDA) ndipo ndi ma catheter okhawo omwe amavomerezedwa kuti athetse kufalikira kwa matenda a Atrioventricular Nodal Reentrant Tachycardia (AVNRT).  

AVNRT ndi mtundu wodziwika kwambiri wa tachycardia ya supraventricular (SVT), ndipo ndiyowopsa kwambiri pamtima, yomwe ili ndi milandu 89,000 chaka chilichonse ndikukula. Pafupifupi 35% ya milandu ya AVNRT imapezeka mwa ana, kapena, ana osapitirira zaka 18. Chifukwa cha kuyendayenda kwachilendo mkati mwa kayendedwe ka mtima, AVNRT imayambitsa kuthamanga kwambiri kwa mtima, ndipo ngati sikunachiritsidwe, ikhoza kusokoneza mphamvu ya mtima kupopera. kawirikawiri, zomwe zimatsogolera ku palpitations, kupepuka, ndi syncope.

Catheter ablation ndi njira yoyamba yochizira AVNRT. Ma Catheter a Freezor ndi Freezor Xtra ndi osinthika, zida zogwiritsidwa ntchito kamodzi zomwe zimagwiritsidwa ntchito kuziziritsa minofu yamtima ndikuletsa ma siginecha amagetsi osafunikira mkati mwa mtima. Banja la Freezor limathandizira chithandizo chokhazikika komanso chogwira mtima cha cryoablation ndipo chathandiza odwala opitilira 140,000 m'maiko 67. Cryoablation ikhoza kuchepetsa chiopsezo cha AV block yosatha, vuto la njira za AVNRT zochitidwa ndi ma radiofrequency (RF) ablation zomwe zimabweretsa kusokoneza pang'ono kapena kwathunthu kwa ma siginecha amagetsi amtima, zomwe zimasokoneza kwambiri kuthamanga kwa mtima.

"Pali zida zochepa zomwe zimavomerezedwa kuti zithandizire odwala matenda amtima a ana masiku ano," adatero Bryan C. Cannon, MD, pulofesa wa ana komanso pulezidenti wakale wa Pediatric & Congenital Electrophysiology Society (PACES), bungwe lalikulu kwambiri padziko lonse lapansi la ana. madokotala apadera a rhythm. "Pokhala ndi chiwonjezeko cha FDA, ma catheters a Freezor ndi Freezor Xtra cardiac cryoablation catheters amalola ngakhale odwala amtima aang'ono kwambiri kupeza njira zotetezeka, zowonjezera moyo zomwe zingathandize kupititsa patsogolo chisamaliro cha mtima cha AVNRT."

Chivomerezo chakukula kwachidziwitsochi chikuthandizidwa ndi zotsatira zochokera ku ICY-AVNRT ndi maphunziro angapo a ana osasinthika, opezeka pakati pamagulu ambiri omwe amasonyeza chitetezo ndi mphamvu ya chithandizo cha AVNRT pogwiritsa ntchito ma catheters a Freezor ndi Freezor Xtra cardiac cryoablation. Deta ya ICY-AVNRT inanena kuti njira yabwino kwambiri ya 95% popanda malipoti a pacemaker osatha chifukwa cha AV block.1 Umboni wokulirapo, kuphatikizapo maphunziro khumi ndi asanu ndi limodzi, adawonanso kuchuluka kwa mphamvu komanso zochitika zochepa.2-17

Catheter ya Freezor cardiac cryoablation catheter inayamba kugulitsidwa ku US kuti igwiritsidwe ntchito ndi akuluakulu a AVNRT mu 2003, yotsatiridwa ndi Freezor Xtra cardiac cryoablation catheter mu 2016. Banja la Freezor la cryoablation catheters limaphatikizaponso Freezor MAX cardiac cryoablation, yomwe imavomerezedwa ndi catheter. Gwiritsani ntchito molumikizana ndi Arctic Front™ Advance cryoballoon pochiza matenda a atrial fibrillation (AF).

"Ndife onyadira ntchito yathu ndi PACES ndi FDA munjira yoyamba yamtunduwu, yothandiza anthu ambiri kuthana ndi vuto la odwala," atero a Rebecca Seidel, purezidenti wa bizinesi ya Cardiac Ablation Solutions, yomwe ndi gawo la bizinesi. Cardiovascular Portfolio ku Medtronic. "Kudzipereka kwathu kothandizana ndi kukulitsa udindo wapadera wa chithandizochi pochiza odwala AVNRT kukuwonetsa chidaliro chathu pachitetezo chotsimikizika komanso mphamvu yaukadaulo wathu wakulira."

Medtronic yachita upangiri waukadaulo wa cryoablation, wokhala ndi umboni wotsogola wamakampani komanso wochulukirapo, kuphatikiza chitetezo chotsimikizika ndi kuthandizira pochiza AF ndi AVNRT. Mpaka pano, odwala opitilira miliyoni imodzi adathandizidwa ndi Medtronic cryoablation therapy padziko lonse lapansi.

Mothandizana ndi asing'anga otsogola, ofufuza, ndi asayansi padziko lonse lapansi, Medtronic imapereka ukadaulo wotsogola waukadaulo wazothandizira komanso maopaleshoni a matenda amtima ndi matenda amtima. Kampaniyo imayesetsa kupereka zinthu ndi ntchito zapamwamba kwambiri zomwe zimapereka phindu lazachipatala komanso zachuma kwa ogula ndi opereka chithandizo padziko lonse lapansi.