FDA inobvumidza kurapwa kutsva kwevana kweyakajairika moyo mutinhimira mamiriro

Medtronic plc nhasi yazivisa kuti Freezor™ neFreezor™ Xtra Cardiac Cryoablation Catheters inotenderwa neUS Food and Drug Administration (FDA) uye ndiyo chete macatheter ekubvisa anobvumidzwa kurapa kuwanda kuri kukura kwevana Atrioventricular Nodal Reentrant Tachycardia (AVNRT).  

AVNRT ndiyo yakajairika nzira ye supraventricular tachycardia (SVT), uye inotyisa hupenyu husina kujairika moyo rhythm, ine 89,000 kesi gore rega rega uye ichikura. Inenge 35% yezviitiko zveAVNRT zvinoitika muvana, kana, vana vari pasi pemakore 18. Nekuda kwedunhu risina kujairika mukati memaitiro ekufambisa kwemoyo, AVNRT inokonzera kukurumidza kwemoyo rhythm, uye kana isina kurapwa, inogona kukanganisa kukwanisa kwemoyo kupomba. kazhinji, zvichiita kuti palpitations, lightheadedness, uye syncope.

Catheter ablation chirongwa chekutanga chekurapa kweAVNRT. Iwo Freezor uye Freezor Xtra Catheters anochinjika, anoshandisa-kamwe-kushandisa anoshandiswa kuomesa matishu emwoyo uye kuvhara zvisina basa masaini emagetsi mukati memoyo. Mhuri yeFreezor inogonesa yakachengeteka uye inoshanda focal cryoablation therapy uye yakarapa vanopfuura 140,000 varwere munyika makumi matanhatu nenomwe. Cryoablation inogona kuderedza njodzi yekusingaperi AV block, complication yeAVNRT maitiro anoitwa neradiofrequency (RF) ablations inoguma nekukanganiswa kudiki kana kuzere kwemasaini emagetsi emwoyo, izvo zvinokanganisa mutinhimira wemoyo.

"Kune michina mishoma inotenderwa kurapa varwere vemwoyo yakaoma yevana nhasi," akadaro Bryan C. Cannon, MD, purofesa wevana uye purezidhendi wekare wePediatric & Congenital Electrophysiology Society (PACES), sangano rakakura kwazvo pasi rose revana. rhythm specialty doctors. "Nekuwedzera kuri kuita FDA, maFreezor neFreezor Xtra cardiac cryoablation catheters anobvumira kunyangwe mudiki wevarwere vemoyo kuwana tekinoroji yakachengeteka, inovandudza hupenyu inozobatsira kufambisira mberi kutarisirwa kwemoyo kweAVNRT."

Chiratidzo chekuwedzera kubvumirwa kunotsigirwa nemigumisiro kubva kuICY-AVNRT uye zvidzidzo zvevana zvakasiyana-siyana, zvakasiyana-siyana zvakaratidza kuchengetedzwa uye kushanda kwekurapa kweAVNRT uchishandisa Freezor uye Freezor Xtra cardiac cryoablation catheters. ICY-AVNRT data yakashuma kubudirira kwemaitiro e95% pasina mishumo yekusingaperi pacemaker nekuda kwekuvhara AV block.1 Uchapupu hukuru hwehupupu, kusanganisira zvidzidzo gumi nematanhatu, zvakacherechedzawo maitiro ekushanda kwepamusoro uye zviitiko zvakaderera zvakashata.2-17

Iyo Freezor cardiac cryoablation catheter yakatanga kuwanikwa mukutengeserana muUS kuti ishandiswe nevanhu vakuru veAVNRT muna 2003, ichiteverwa neFreezor Xtra cardiac cryoablation catheter muna 2016. Mhuri yeFreezor ye cryoablation catheters inosanganisirawo Freezor MAX cardiac cryoablation, iyo inobvumirwa catheter. shandisa pamwe chete neArctic Front™ Advance cryoballoon yekurapa atrial fibrillation (AF).

"Tinodada nebasa redu nePACES neFDA muchirongwa ichi chekutanga-che-chayo, chevatori vechikamu chekugadzirisa huwandu hwevarwere," akadaro Rebecca Seidel, purezidhendi webhizinesi reCardiac Ablation Solutions, rinova chikamu che. iyo Cardiovascular Portfolio kuMedtronic. "Kuzvipira kwakagovaniswa kwekubatana pamwe nekukura chinzvimbo chekurapa uku chekurapa varwere veAVNRT kunoratidza chivimbo chedu mukuchengetedzeka uye kushanda kwetekinoroji yedu yekuchema."

Medtronic yakapayona tekinoroji ye cryoablation, ine indasitiri inotungamira uye yakakura huwandu hwehumbowo, hunosanganisira kuchengetedzwa kwakaratidza uye kugona mukurapa AF neAVNRT. Parizvino, varwere vanopfuura miriyoni imwe vakarapwa neMedtronic cryoablation therapy pasi rose.

Mukubatana nevarapi vanotungamira, vaongorori, uye masayendisiti pasi rese, Medtronic inopa yakafararira siyana yehunyanzvi hwekurapa tekinoroji yekupindira uye yekuvhiya kurapwa kwechirwere chemoyo uye chemoyo arrhythmias. Iyo kambani inoyedza kupa zvigadzirwa nemasevhisi emhando yepamusoro anoendesa kukosha kwekiriniki nehupfumi kune vatengi vehutano uye vanopa pasirese.