Ua ʻae ʻo FDA i ka mālama ʻana i nā keiki hou i kahi kūlana puʻuwai maʻamau

Ua hoʻolaha ʻo Medtronic plc i kēia lā ua ʻae ʻia ka Freezor™ a me Freezor™ Xtra Cardiac Cryoablation Catheters e ka US Food and Drug Administration (FDA) a ʻo ia wale nō nā catheters ablation i ʻae ʻia e mālama i ka ulu nui ʻana o ka pediatric Atrioventricular Nodal Reentrant Tachycardia (AVNRT).  

ʻO ka AVNRT ke ʻano maʻamau o ka supraventricular tachycardia (SVT), a he puʻuwai puʻuwai ʻino weliweli, me 89,000 mau hihia i kēlā me kēia makahiki a ke ulu nei. Ma kahi kokoke i 35% o nā maʻi AVNRT i loaʻa i nā pediatrics, a i ʻole, nā keiki ma lalo o ka makahiki 18. Ma muli o kahi kaapuni ʻokoʻa i loko o ka ʻōnaehana hoʻokele o ka naʻau, ʻo ka AVNRT ke kumu o ka puʻuwai wikiwiki loa, a inā haʻalele ʻole ʻia, hiki ke hoʻopilikia i ka mana o ka puʻuwai e paʻi. maʻamau, alakaʻi i ka palpitations, lightheadedness, and syncope.

ʻO ka Catheter ablation kahi lāʻau lapaʻau mua no ka mālama ʻana i ka AVNRT. ʻO ka Freezor a me Freezor Xtra Catheters he mea maʻalahi, hoʻohana hoʻokahi i hoʻohana ʻia e hoʻokuʻu i ka ʻiʻo cardiac a pale i nā hōʻailona uila pono ʻole i loko o ka puʻuwai. Hiki i ka ʻohana Freezor ke palekana a me ka maikaʻi o ka focal cryoablation therapy a ua mālama ʻo ia ma mua o 140,000 mau maʻi ma waena o 67 mau ʻāina. Hiki i ka Cryoablation ke ho'ēmi i ka pilikia o ka poloka AV mau, he hoʻopiʻi o nā kaʻina hana AVNRT i hana ʻia me ka radiofrequency (RF) ablation e hopena i ka pau ʻana a i ʻole ka pau ʻana o nā hōʻailona uila o ka puʻuwai, kahi e hoʻopilikia weliweli ai i ka puʻuwai.

"He mau mea liʻiliʻi loa i ʻae ʻia e mālama i nā maʻi maʻi cardiology pediatric paʻakikī i kēia lā," wahi a Bryan C. Cannon, MD, ke kaukaʻi o nā pediatrics a me ka pelekikena mua o ka Pediatric & Congenital Electrophysiology Society (PACES), ka hui nui loa ma ka honua no nā pediatric. nā kauka kūikawā rhythm. "Me ka hoʻonui hōʻike FDA, ʻo ka Freezor a me Freezor Xtra cardiac cryoablation catheters e ʻae i ka ʻōpio o nā mea maʻi cardiology e komo i kahi ʻenehana palekana, hoʻonui i ke ola e kōkua i ka mālama ʻana i ka naʻau no AVNRT."

Kākoʻo ʻia ka ʻae ʻana o ka hoʻonui ʻia ʻana e nā hopena mai ka ICY-AVNRT a me ka nui o nā pediatric randomized, multi-center study i hōʻike i ka palekana a me ka pono o ka mālama ʻana iā AVNRT me ka hoʻohana ʻana i ka Freezor a me Freezor Xtra cardiac cryoablation catheters. Ua hōʻike ka ʻikepili ICY-AVNRT i ka kūleʻa o ke kaʻina hana o 95% me ka ʻole o nā hōʻike o ka pacemaker mau loa ma muli o ka hoʻopiha ʻana i ka poloka AV.

ʻO ka Freezor cardiac cryoablation catheter ua loaʻa mua i ke kūʻai aku ma US no ka hoʻohana ʻana o nā pākeke i ka AVNRT ma 2003, a ukali ʻia e ka Freezor Xtra cardiac cryoablation catheter ma 2016. ʻO ka ʻohana Freezor o nā cryoablation catheters pū kekahi me ka Freezor MAX cardiac cryoablation catheter, i ʻae ʻia no ka catheter. hoʻohana pū me ka Arctic Front™ Advance cryoballoon no ka mālama ʻana i ka fibrillation atrial (AF).

"Haʻaheo mākou i kā mākou hana me PACES a me FDA i kēia ʻano mua o kāna ʻano, multi-stakeholder initiative e hoʻoponopono i kahi heluna maʻi koʻikoʻi," wahi a Rebecca Seidel, pelekikena o ka ʻoihana Cardiac Ablation Solutions, ʻo ia kahi ʻāpana o ka Cardiovascular Portfolio ma Medtronic. "ʻO ka ʻae like ʻana e hui pū a ulu i ke kūlana kūʻokoʻa o kēia therapy e mālama i nā maʻi AVNRT e hōʻike ana i ko mākou hilinaʻi i ka palekana a me ka pono o kā mākou ʻenehana cryoablation."

Ua hoʻokumu ʻo Medtronic i ka ʻenehana cryoablation, me kahi ʻoihana alakaʻi a me ka nui o nā hōʻike hōʻike, me ka palekana a me ka pono i hōʻoia ʻia i ka mālama ʻana iā AF a me AVNRT. I kēia lā, ʻoi aku ma mua o hoʻokahi miliona mau maʻi i mālama ʻia me Medtronic cryoablation therapy ma ka honua holoʻokoʻa.

Ma ka launa pū ʻana me nā kauka lapaʻau alakaʻi, nā mea noiʻi, a me nā ʻepekema ma ka honua holoʻokoʻa, hāʻawi ʻo Medtronic i ka laulā ākea o ka ʻenehana lapaʻau hou no ka mālama ʻana a me ka mālama ʻana i ka maʻi cardiovascular a me nā arrhythmias cardiac. Hoʻoikaika ka hui e hāʻawi i nā huahana a me nā lawelawe o ke kūlana kiʻekiʻe loa e hāʻawi i ka waiwai lapaʻau a me ka waiwai waiwai i nā mea kūʻai olakino a me nā mea hoʻolako a puni ka honua.