{"id":1690,"date":"2022-03-05T11:07:51","date_gmt":"2022-03-05T03:07:51","guid":{"rendered":"http:\/\/site.tamthuvn.com\/?p=1690"},"modified":"2022-06-06T03:16:23","modified_gmt":"2022-06-05T19:16:23","slug":"cty-biotronik-datmuc-an-toan-cao-nhat-trong-cac-nha-san-xuatmay-dieu-tri-nhip-tim","status":"publish","type":"post","link":"https:\/\/tamthuvn.com\/en\/2022\/03\/cty-biotronik-datmuc-an-toan-cao-nhat-trong-cac-nha-san-xuatmay-dieu-tri-nhip-tim\/","title":{"rendered":"Cty Biotronik \u0111\u1ea1t m\u1ee9c an to\u00e0n cao nh\u1ea5t trong c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t m\u00e1y \u0111i\u1ec1u tr\u1ecb nh\u1ecbp tim."},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"1690\" class=\"elementor elementor-1690\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7c5e56f0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7c5e56f0\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6be5d35e\" data-id=\"6be5d35e\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-79568dd1 elementor-widget elementor-widget-text-editor\" data-id=\"79568dd1\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\n<figure class=\"wp-block-table\">\n<table>\n<tbody>\n<tr>\n<td>\u0110i\u1ec1u m\u00e0 kh\u00f4ng c\u00f3 c\u00f4ng ty m\u00e1y t\u1ea1o nh\u1ecbp (v\u00e0 m\u00e1y ph\u00e1 rung, m\u00e1y \u0111i\u1ec1u tr\u1ecb suy tim) n\u00e0o ph\u1ee7 nh\u1eadn l\u00e0 Cty Biotronik l\u00e0 c\u00f4ng ty \u0111\u00e3 \u0111\u1ea1t m\u1ee9c an to\u00e0n cao nh\u1ea5t, \u0111\u00e3 kh\u00f4ng c\u00f3 b\u1ea5t c\u1ee9 FDA recall n\u00e0o trong v\u00f2ng 10 n\u0103m nay. Trong\u00a0<a href=\"https:\/\/systolicvn.com\/Recall.html#RecallSummary\">th\u1eddi gian n\u00e0y<\/a><br \/><img decoding=\"async\" src=\"\/NVUImage\/FidelisShock.jpg\" alt=\"Sprint Fidelis shock\" \/>Cty Medtronic n\u0103m 2007 b\u1ecb c\u01a1 quan FDA (USA) ra l\u1ec7nh recall (thu h\u1ed3i) d\u00e2y s\u1ed1c Sprint Fidelis \u0111\u00e3 t\u1ea1o \u0111au \u0111\u1edbn t\u1eadn c\u00f9ng cho m\u1ed9t s\u1ed1 kh\u00e1 l\u1edbn BN, k\u1ec3 c\u1ea3 m\u1ed9t s\u1ed1 BN \u1edf VN. H\u00ecnh b\u00ean ph\u1ea3i (t\u1eeb BS Ip, Michigan State U) l\u00e0 qu\u00e1 tr\u00ecnh nh\u1ecbp \u0111\u01b0\u1ee3c m\u00e1y ph\u00e1t hi\u1ec7n v\u00ec d\u00e2y s\u1ed1c h\u01b0 \u0111\u00e3 \u0111\u01b0a \u0111\u1ebfn BN b\u1ecb 6 s\u1ed1c li\u00ean t\u1ee5c, s\u1ed1 s\u1ed1c \u0111i\u1ec1u tr\u1ecb t\u1ed3i \u0111a cho m\u1ed9t c\u01a1n lo\u1ea1n nh\u1ecbp trong c\u00e1c m\u00e1y ph\u00e1 rung Medtronic. Hi\u1ec7n nay\u00a0<a href=\"https:\/\/systolicvn.com\/LeadRecall.html#Fidelis\">m\u1ee9c d\u00e2y h\u01b0 c\u1ea7n ph\u1ea3i thay \u0111\u1ec3 tr\u00e1nh b\u1ecb b\u00e3o s\u1ed1c l\u1ea7m<\/a>\u00a0t\u1eeb 16% (trung b\u00ecnh)\u00a0\u0111\u1ebfn 37%.K\u1ebf \u0111\u1ebfn Cty St Jude \u0111\u00e3 ph\u1ea3i recall d\u00e2y s\u1ed1c Riata, Riata ST n\u0103m 2011, d\u00e2y<img decoding=\"async\" src=\"\/NVUImage\/RiataExternalizedConductor.jpg\" alt=\"R\u00edata externalized conductor\" \/>\u00a0th\u1ea5t tr\u00e1i QuickFlex v\u00e0 QuickSite n\u0103m 2012, t\u1ea5t c\u1ea3 v\u00ec s\u1ef1 c\u1ed1 d\u00e2y \u0111\u1ed3ng l\u00f2i ra.\u00a0<a href=\"https:\/\/systolicvn.com\/Riata6.html\">D\u00e2y \u0111i\u1ec7n c\u1ef1c s\u00f4c Riata c\u1ee7a Cty St Jude c\u00f3 s\u1ef1 c\u1ed1 d\u00e2y \u0111\u1ed3ng l\u00f2i ra v\u1edbi m\u1ee9c s\u1ef1 c\u1ed1 &gt;24%<\/a>. Tuy nhi\u00ean\u00a0<a href=\"https:\/\/systolicvn.com\/Riata6.html#FDA1208\">c\u01a1 quan FDA c\u0169ng \u0111\u00e3 quan t\u00e2m v\u00e0 \u0111\u1eb7c bi\u1ec7t khuy\u00ean c\u00e1c BN c\u1ea7n ph\u1ea3i ki\u1ebbm tra t\u00ecnh tr\u1ea1ng d\u00e2y v\u1edbi x-quang<\/a>. Cho \u0111\u1ebfn nay c\u00e1ch gi\u1ea3i quy\u1ebft c\u00e1c d\u00e2y \u0111i\u1ec7n c\u1ef1c n\u00e0y v\u1eabn ch\u01b0a \u0111\u01b0\u1ee3c th\u1ed1ng nh\u1ea5t. D\u00e2y Durata, \u0111\u00e3 thay th\u1ebf Riata, l\u00e0\u00a0<a href=\"https:\/\/systolicvn.com\/Riata5.html\">\u0111\u1ec1 t\u00e0i b\u00e0n c\u1ea3i s\u00f4i n\u1ed7i \u1edf t\u1ea5t c\u1ea3 c\u00e1c h\u1ed9i ngh\u1ecb tim m\u1ea1ch l\u1edbn<\/a>, tr\u1eeb \u1edf VN, v\u1ec1 an to\u00e0n l\u00e2u d\u00e0i.\u00a0Ngo\u00e0i c\u00e1c recall nghi\u00eam tr\u1ecdng tr\u00ean, c\u00e1c c\u00f4ng ty Medtronic v\u00e0 St Jude c\u0169ng \u0111\u00e3 c\u00f3 nhi\u1ec1u recall class II c\u00e1c m\u00e1y \u0111i\u1ec1u tr\u1ecb nh\u1ecbp tim v\u00e0 d\u00e2y \u0111i\u1ec7n c\u1ef1c kh\u00e1c (xem\u00a0<a href=\"https:\/\/systolicvn.com\/Recall.html#RecallSummary\">t\u00f3m t\u1eaft<\/a>).C\u0169ng trong th\u1eddi gian n\u00e0y c\u1ea3 2 c\u00f4ng ty Medtronic v\u00e0 St Jude \u0111\u1ec1u \u0111\u00e3 b\u1ecb FDA g\u1eedi th\u01b0 c\u1ea3nh c\u00e1o v\u1ec1 quy tr\u00ecnh thi\u1ebft k\u1ebf c\u00e1c thi\u1ebft b\u1ecb. Cty Medtronic b\u1ecb\u00a0<a href=\"http:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/ucm191541.htm\">th\u1eed c\u1ea3nh c\u00e1o n\u0103m 2009<\/a>.<a href=\"http:\/\/www.fda.gov\/downloads\/AboutFDA\/CentersOffices\/OfficeofGlobalRegulatoryOperationsandPolicy\/ORA\/ORAElectronicReadingRoom\/UCM328488.pdf\">Th\u01b0 c\u1ea3nh c\u00e1o m\u1edbi nh\u1ea5t \u0111\u00e3 \u0111\u01b0\u1ee3c g\u1eedi \u0111\u1ebfn Cty St Jude th\u00e1ng 10, 2012<\/a>, v\u00e0 n\u00eau l\u00ean c\u00e1c\u00a0<a href=\"https:\/\/systolicvn.com\/Riata6.html#FDADurata\">khi\u1ebfm khuy\u1ebft trong giai \u0111o\u1ea1n ph\u00ea chu\u1ea9n thi\u1ebft k\u1ebf (design validation) d\u00e2y s\u1ed1c Durata<\/a>. V\u1edbi c\u00e1c khi\u1ebfm khuy\u1ebft n\u00e0y, l\u00e0m sao Cty St Jude c\u00f3 th\u1ec3 tuy\u00ean b\u1ed1 l\u00e0 d\u00e2y s\u1ed1c Durata an to\u00e0n?Trong c\u1ea3 th\u1eddi gian n\u00e0y, Cty Biotronik \u0111\u00e3 kh\u00f4ng c\u00f3 recall ho\u1eb7c nh\u1eadn th\u01b0 c\u1ea3nh c\u00e1o n\u00e0o h\u1ebft!Trong khi m\u00e1y t\u1ea1o nh\u1ecbp\/ph\u00e1 rung ch\u1ec9 c\u00f3 th\u1eddi gian ho\u1ea1t \u0111\u1ed9ng 5-15 n\u0103m, d\u00e2y \u0111i\u1ec7n c\u1ef1c c\u00f3 th\u1ec3 \u1edf trong ng\u01b0\u1eddi b\u1ea1n 20-30 n\u0103m. N\u1ebfu d\u00e2y c\u00f3 s\u1ef1 c\u1ed1, th\u00ec \u1edf VN ch\u1ec9 c\u00f3 th\u1ec3 b\u1ecf d\u00e2y l\u1ea1i trong ng\u01b0\u1eddi v\u00e0 th\u00eam d\u00e2y kh\u00e1c. Nh\u01b0ng, t\u0129nh m\u1ea1ch c\u1ee7a con ng\u01b0\u1eddi \u0111\u00e2u c\u00f3 ph\u1ea3i r\u1ed9ng th\u00eanh thang, mu\u1ed1n c\u1ea5y v\u00e0o bao nhi\u00eau d\u00e2y \u0111i\u1ec7n c\u1ef1c c\u0169ng \u0111\u01b0\u1ee3c? \u0110\u00e3 c\u00f3 nhi\u1ec1u BN khi thay m\u00e1y \u0111\u00e3 ph\u1ea3i thay vai c\u1ea5y m\u00e1y, v\u00ec khi th\u00e1o m\u00e1y ra, th\u00ec BS ph\u00e1t hi\u1ec7n d\u00e2y \u0111i\u1ec7n c\u1ef1c kh\u00f4ng th\u1ec3 s\u1eed d\u1ee5ng l\u1ea1i \u0111\u01b0\u1ee3c (khi d\u00e2y b\u1ecb \u0111\u1ed9ng th\u00ec h\u01b0), v\u00e0 t\u0129nh m\u1ea1ch \u0111\u00e3 h\u1eb9p l\u1ea1i n\u00ean kh\u00f4ng th\u1ec3 \u0111\u01b0a d\u00e2y m\u1edbi qua. \u1ede \u00c2u-M\u1ef9,\u00a0khi d\u00e2y h\u01b0 th\u00ec c\u00f3 th\u1ec3 \u0111\u1ebfn BS chuy\u00ean m\u00f4n r\u00fat d\u00e2y, \u0111\u1ec3 l\u1ea5y d\u00e2y \u0111i\u1ec7n c\u1ef1c ra. Th\u1ee7 thu\u1eadt n\u00e0y c\u00f3 m\u1ee9c s\u1ef1 c\u1ed1 nh\u1ecf, nh\u01b0ng kh\u00f4ng ph\u1ea3i 0. Ngay c\u1ea3 \u1edf c\u00e1c trung t\u00e2m nhi\u1ec1u kinh nghi\u1ec7m\u00a0<a href=\"http:\/\/content.onlinejacc.org\/article.aspx?articleid=1140430\">m\u1ee9c s\u1ef1 c\u1ed1 l\u00e0 1,4%, m\u1ee9c t\u1eed vong l\u00e0 0,28%<\/a>! \u0110\u00e2y l\u00e0 l\u00fd do nhi\u1ec1u d\u00e2y Riata \u0111\u00e3 b\u1ecb s\u1ef1 c\u1ed1 d\u00e2y \u0111\u1ed3ng l\u00f2i ra trong t\u0129nh m\u1ea1ch, m\u00e0 BS v\u1eabn do d\u1ef1 kh\u00f4ng r\u00fat ra. Tuy nhi\u00ean \u0111\u00e9n khi d\u00e2y b\u1ecb h\u01b0 v\u1ec1 ph\u01b0\u01a1ng di\u1ec7n \u0111i\u1ec7n (s\u1ed1c l\u1ea7m, c\u00f3 nhi\u1ec5u, d\u00e2y \u0111\u1ed3ng \u0111\u1ee9t) th\u00ec BS s\u1ebd ph\u1ea3i c\u1ea5y d\u00e2y m\u1edbi.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n\n\n\n<p>V\u1ec1 ph\u01b0\u01a1ng di\u1ec7n an to\u00e0n d\u00e2y \u0111i\u1ec7n c\u1ef1c th\u00ec<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Trong qu\u00e1 tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng t\u1eeb n\u0103m 1963 \u0111\u1ebfn nay (12\/2013), &gt;50 n\u0103m, ch\u1ec9 c\u00f3 Cty Biotronik l\u00e0\u00a0duy nh\u1ea5t\u00a0\u0111\u00e3 kh\u00f4ng c\u00f3 b\u1ea5t c\u1ee9 recall d\u00e2y \u0111i\u1ec7n c\u1ef1c n\u00e0o c\u1ea3! Con s\u1ed1 KH\u00d4NG, zero, nada, &#8230;!<\/li>\n<\/ul>\n\n\n\n<p>\u0110\u00e3 c\u00f3 nhi\u1ec1u gi\u1ea3i th\u00edch t\u00ecnh tr\u1ea1ng &#8220;b\u1ea5t th\u01b0\u1eddng&#8221; 0 recall c\u1ee7a Cty Biotronik, nh\u01b0 d\u01b0\u1edbi \u0111\u00e2y<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Cty Biotronik c\u00f3 tr\u1ee5 s\u1edf \u1edf \u00c2u-Ch\u00e2u n\u00ean kh\u00f4ng ch\u1ecbu s\u1ef1 gi\u00e1m s\u00e1t c\u1ee7a FDA.\u00a0\n<ul>\n<li>V\u00ec c\u00f3 cung c\u1ea5p m\u00e1y v\u00e0o th\u1ecb tr\u01b0\u1eddng M\u1ef9, n\u00ean Cty Biotronik ph\u1ea3i ch\u1ecbu s\u1ef1 ki\u1ec3m so\u00e1t c\u1ee7a FDA nh\u01b0 Cty Medtronic, St Jude. H\u00e0ng n\u0103m thanh tra FDA c\u00f3 \u0111\u1ebfn tr\u1ee5 s\u1edf Biotronik \u1edf Berlin, CHLB \u0110\u1ee9c, ki\u1ec3m tra quy tr\u00ecnh thi\u1ebft k\u1ebf v\u00e0 s\u00e3n xu\u1ea5t. C\u00e1c Cty Medtronic v\u00e0 St Jude \u0111\u1ec1u c\u00f3 c\u01a1 s\u1edf thi\u1ebft k\u1ebf v\u00e0 s\u00e3n xu\u1ea5t thi\u1ebft b\u1ecb \u1edf ngo\u00e0i M\u1ef9, c\u0169ng ph\u1ea3i ch\u1ecbu c\u00e1c cu\u1ed9c thanh tra t\u01b0\u01a1ng t\u1ef1.\u00a0<\/li>\n<li>C\u00e1c b\u1ea1n \u0111\u01b0\u1ee3c c\u1ea5y b\u1ed9 m\u00e1y \u0111i\u1ec1u tr\u1ecb nh\u1ecbp tim c\u1ee7a Medtronic v\u00e0 St Jude c\u00f3 bi\u1ebft th\u1eadt s\u1ef1 c\u00e1c thi\u1ebft b\u1ecb \u0111\u00f3 \u0111\u00e3 \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf v\u00e0 s\u00e3n xu\u1ea5t \u1edf \u0111\u00e2u kh\u00f4ng? Kh\u00f4ng nh\u1ea5t thi\u1ebft l\u00e0 t\u1eeb M\u1ef9 \u0111\u00e2u! Ngo\u00e0i ra c\u00f2n c\u00f3 m\u1ed9t s\u1ed1 m\u00e1y \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf v\u00e0 s\u00e3n xu\u1ea5t ri\u00eang cho th\u1ecb tr\u01b0\u1eddng \u0111\u1ec7 tam th\u1ebf gi\u1edbi, nh\u01b0 m\u00e1y t\u1ea1o nh\u1ecbp St Jude Sustain!<\/li>\n<\/ul>\n<\/li>\n<li>Cty Biotronik c\u00f3 th\u1ecb tr\u01b0\u1eddng nh\u1ecf n\u00ean c\u00e1c s\u1ef1 c\u1ed1 \u1edf m\u1ee9c th\u1ea5p\n<ul>\n<li>Cty Biotronik n\u0103m 2011 c\u00f3 doanh s\u1ed1 tr\u00ean 1 t\u1ef7 Euro (&gt;1,3 t\u1ef7 USD), m\u00e0 &gt;50% l\u00e0 t\u1eeb c\u00e1c thi\u1ebft b\u1ecb \u0111i\u1ec1u tr\u1ecb nh\u1ecbp tim. \u0110\u00e2y kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ed9t c\u00f4ng ty v\u1edbi doanh s\u1ed1 v\u00e0i tri\u1ec7u USD \u0111\u00e2u!\u00a0<\/li>\n<li>Ngo\u00e0i ra, doanh s\u1ed1 v\u1ec1 thi\u1ebft b\u1ecb \u0111i\u1ec1u tr\u1ecb nh\u1ecbp tim c\u1ee7a c\u00e1c Cty Medtronic v\u00e0 St Jude c\u0169ng kh\u00f4ng ph\u1ea3i g\u1ea5p 10 l\u1ea7n doanh s\u1ed1 Cty Biotronik.\u00a0<a href=\"http:\/\/www.medtronic.com\/about-medtronic\/business-overview\/crdm\/index.htm\">Doanh thu n\u0103m 2011 thi\u1ebft b\u1ecb \u0111i\u1ec1u tr\u1ecb nh\u1ecbp tim c\u1ee7a Medtronic<\/a>\u00a0ch\u1ec9 l\u00e0 5 t\u1ef7 USD (t\u1ed5ng s\u1ed1 doanh thu l\u00e0 16 t\u1ef7 USD).\u00a0<a href=\"http:\/\/www.wikinvest.com\/stock\/St._Jude_Medical_%28STJ%29\">Doanh thu thi\u1ebft b\u1ecb \u0111i\u1ec1u tr\u1ecb nh\u1ecbp tim c\u1ee7a Cty St Jude n\u0103m 2011 l\u00e0 59% c\u1ee7a 4,7 t\u1ef7 USD<\/a>\u00a0(=2,8 t\u1ef7 USD).<\/li>\n<li>M\u00e0 c\u00e1c c\u01a1 quan ch\u1ee9c tr\u00e1ch, nh\u01b0 FDA, quan t\u00e2m v\u1ec1 t\u1ea5t c\u1ea3 c\u00e1c s\u1ef1 c\u1ed1. Th\u00ed d\u1ee5 \u0111i\u1ec3n h\u00ecnh l\u00e0\u00a0<a href=\"http:\/\/en.wikipedia.org\/wiki\/Telectronics\">Cty Telectronics<\/a>, m\u1ed9t Cty c\u00f9ng th\u1eddi v\u1edbi Biotronik, \u0111\u01b0\u1ee3c th\u00e0nh l\u1eadp n\u0103m 1963, \u0111\u00e3 b\u1ecb x\u00f3a s\u1ed5 n\u0103m 1996 ch\u1ec9 v\u00ec v\u00e0i BN t\u1eed vong do thi\u1ebft k\u1ebf sai l\u1ea7m d\u00e2y \u0111i\u1ec7n c\u1ef1c nh\u0129.\u00a0<a href=\"http:\/\/www.theheart.org\/article\/518689.do\">C\u00f4ng ty Guidant<\/a>\u00a0c\u0169ng b\u1ecb x\u00f3a s\u1ed5 sau khi c\u00f3 m\u1ed9t v\u00e0i BN \u0111\u1ed9t t\u1eed n\u0103m 2005 do m\u00e1y ph\u00e1 rung kh\u00f4ng ph\u00e1t s\u1ed1c \u0111\u01b0\u1ee3c khi c\u1ea7n do thi\u1ebft k\u1ebf kh\u00f4ng an to\u00e0n.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>L\u00fd do Cty Biotronik \u0111\u1ea1t \u0111\u01b0\u1ee3c m\u1ee9c an to\u00e0n cao, th\u1eadt ra r\u1ea5t \u0111\u01a1n gi\u1ea3n: truy\u1ec1n th\u1ed1ng an to\u00e0n BN tr\u00ean h\u1ebft. Cty n\u00e0o c\u0169ng c\u00f3 nh\u1eefng tuy\u00ean b\u1ed1 t\u01b0\u01a1ng t\u1ef1. Ch\u00fang t\u00f4i xin \u0111\u01b0\u1ee3c tr\u00ecnh 2 th\u00ed d\u1ee5 b\u00ean d\u01b0\u1edbi \u0111\u1ec3 ch\u1ee9ng minh truy\u1ec1n th\u1ed1ng \u0111\u00f3.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>T\u00e1c gi\u1ea3 b\u00e0i n\u00e0y nguy\u00ean l\u00e0 Ph\u00f3 T\u1ed5ng Gi\u00e1m \u0110\u1ed1c K\u1ef9 thu\u1eadt (Vice-President Engineering) c\u1ee7a chi nh\u00e1nh thi\u1ebft k\u1ebf v\u00e0 s\u00e3n xu\u1ea5t \u1edf M\u1ef9 c\u1ee7a Cty Biotronik. Trong nh\u1ee9ng n\u0103m cu\u1ed1i th\u1eadp ni\u00ean 90. T\u00e1c gi\u1ea3 \u0111\u00e3 l\u00e0m vi\u1ec7c tr\u1ef1c ti\u1ebfp v\u1edbi c\u1ed1\u00a0<a href=\"http:\/\/www.max-schaldach-stiftung.de\/de\/25_Stifter_Max_Schaldach\/index.php\">GS Max Schaldach<\/a>\u00a0(1936-2001), ng\u01b0\u1eddi s\u00e1n l\u1eadp Cty Biotronik. T\u1eeb n\u0103m 1993 \u0111\u1ebfn 1998, Ts Th\u1ed1ng \u0111\u00e3 l\u00e0 ng\u01b0\u1eddi l\u00e3nh \u0111\u1ea1o k\u1ef9 thu\u1eadt nh\u00f3m thi\u1ebft k\u1ebf m\u00e1y ph\u00e1<img decoding=\"async\" src=\"\/NVUImage\/PhylaxAV.jpg\" alt=\"Phylax AV\" \/>\u00a0rung hai bu\u1ed3ng \u0111\u1ea7u ti\u00ean c\u1ee7a Cty Biotronik, m\u00e1y Phylax AV. Ts Th\u1ed1ng v\u00e0 m\u1ed9t k\u1ef9 s\u01b0 kh\u00e1c l\u00e0 t\u00e1c gi\u1ea3 ch\u01b0\u01a1ng tr\u00ecnh\u00a0<a href=\"https:\/\/systolicvn.com\/SmartDetection.html\">Smart Detection<\/a>\u00a0ph\u00e2n bi\u1ec7t ngu\u1ed3n g\u1edbc c\u00e1c c\u01a1n lo\u1ea1n nh\u1ecbp nhanh (th\u1ea5t hay tr\u00ean th\u1ea5t) hi\u1ec7n v\u1eabn c\u00f2n \u0111\u01b0\u1ee3c d\u00f9ng ch\u1ec9 v\u1edbi nh\u1eefng thay \u0111\u1ed5i nh\u1ecf so v\u1edbi ch\u01b0\u01a1ng tr\u00ecnh nguy\u00ean th\u1ee7y trong m\u00e1y Phylax AV. N\u0103m 1997, ch\u01b0\u01a1ng tr\u00ecnh thi\u1ebft k\u1ebf m\u00e1y Phylax AV \u0111\u00e3 k\u1ebft th\u00fac v\u00e0 Cty Biotronik s\u1eeda so\u1ea1n xin c\u1ea5p gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh\u00a0<a href=\"http:\/\/en.wikipedia.org\/wiki\/CE_marking\">CE<\/a>\u00a0(Communaut\u00e9 Europ\u00e9enne). C\u00e1c ho\u1ea1t \u0111\u1ed9ng thi\u1ebft k\u1ebf v\u00e0 ph\u00ea chu\u1ea9n thi\u1ebft k\u1ebf (design validation) c\u1ee7a nh\u00f3m k\u1ef9 s\u01b0 \u1edf M\u1ef9 \u0111\u00e3 ho\u00e0n t\u1ea5t. Giai \u0111o\u1ea1n cu\u1ed1i c\u00f9ng l\u00e0 ph\u00ea chu\u1ea9n \u1edf c\u1ea5p Cty Biotronik. \u1ede giai \u0111o\u1ea1n n\u00e0y, c\u00e1c k\u1ef9 s\u01b0\u00a0ph\u00ea chu\u1ea9n thi\u1ebft k\u1ebf \u0110\u1ee9c t\u1ea1i Berlin kh\u00e1m ph\u00e1 ra l\u00e0 th\u1eddi gian t\u1eeb s\u00f3ng R \u1edf th\u1ea5t \u0111\u1ebfn khi m\u00e1y ph\u00e1t s\u1ed1c chuy\u1ec3n nh\u1ecbp (cardioversion) l\u00e0 100 ms. H\u1ecd \u0111\u00f2i ph\u1ea3i \u0111\u1ea1t 50 ms th\u00ec m\u1edbi an to\u00e0n. M\u1eb7c d\u00f9 t\u1ea5t c\u1ea3 c\u00e1c b\u00e1o c\u00e1o \u0111\u1ec1u cho l\u00e0 an to\u00e0n (kh\u00f4ng t\u1ea1o rung th\u1ea5t)<img decoding=\"async\" src=\"\/NVUImage\/QRS.jpg\" alt=\"QRS\" \/>\u00a0n\u1ebfu s\u1ed1c \u0111\u01b0\u1ee3c ph\u00e1t tr\u01b0\u1edbc gi\u1eefa s\u00f3ng T, c\u00f3 ngh\u0129a l\u00e0 sau 100 ms, nh\u00f3m ph\u00ea chu\u1eabn \u0110\u1ee9c nh\u1ea5t \u0111\u1ecbnh l\u00e0 mu\u1ed1n \u0111\u1ea1t an to\u00e0n t\u1ed1i \u0111a, ph\u1ea3i \u0111\u1ea1t 50 ms. V\u00ec quy\u1ebft \u0111\u1ecbnh n\u00e0y m\u00e0 ch\u1ee9ng nh\u1eadn CE b\u1ecb \u0111\u00ecnh tr\u1ec5 6 th\u00e1ng \u0111\u1ec3 t\u00e1i thi\u1ebft k\u1ebf m\u00e1y. \u0110i\u1ec1u quan tr\u1ecdng \u0111\u1ed9c gi\u1ea3 c\u1ea7n hi\u1ec3u l\u00e0\u00a0trong c\u1ea3 th\u1eddi gian n\u00e0y, GS Schaldach, \u00f4ng ch\u1ee7\u00a0c\u1ee7a Cty Biotronik, \u0111\u00e3 kh\u00f4ng\u00a0can thi\u1ec7p, v\u00ec \u0111\u00e3 giao quy\u00ean ph\u00ea chu\u1ea9n thi\u1ebft k\u1ebf cho nh\u00f3m k\u1ef9 s\u01b0 \u1edf Berlin! Ch\u00fang t\u00f4i c\u00f3 b\u00e0n v\u1edbi c\u00e1c \u0111\u1ed3ng nghi\u1ec7p \u1edf M\u1ef9 v\u00e0 ch\u00fang t\u00f4i \u0111\u1ec1u k\u1ebft lu\u1eadn l\u00e0 chuy\u1ec7n \u0111\u00ecnh tr\u1ec5 nh\u01b0 v\u1eady s\u1ebd kh\u00f4ng bao gi\u1edd x\u1ea3y ra \u01a1 m\u1ed9t Cty M\u1ef9 (Medtronic, St Jude, Boston Scientific). \u1ede M\u1ef9, v\u00ec \u00e1p l\u1ef1c c\u00e1c c\u1ed5 \u0111\u00f4ng, c\u00e1c nh\u00e0 \u0111i\u1ec1u h\u00e0nh c\u00f4ng ty s\u1ebd kh\u00f4ng bao gi\u1edd ch\u1ea5p nh\u1eadn nh\u00f3m ph\u00ea chu\u1ea9n thi\u1ebft k\u1ebf c\u00f3 nhi\u1ec1u quy\u1ec1n nh\u01b0 v\u1eady! \u1ede M\u1ef9, l\u1ecbch tr\u00ecnh (schedule) l\u00e0 t\u1ed1i quan tr\u1ecdng, nh\u1ea5t l\u00e0 khi ch\u1ec9 v\u1ea5p ph\u1ea3i m\u1ed9t v\u1ea5n \u0111\u1ec1 ph\u1ee5!<\/li>\n<li>Th\u1ebf h\u1ec7 d\u00e2y \u0111i\u1ec7n c\u1ef1c s\u1ed1c tr\u01b0\u1edbc \u0111\u00e2y l\u00e0 d\u00e2y\u00a0<a href=\"https:\/\/systolicvn.com\/pdfFiles\/TechnicalDataShockLead.pdf\">Kentrox<\/a>. D\u00e2y n\u00e0y c\u00f3 k\u00edch c\u1edf 9,3 French (1F= 1\/3 mm). Cu\u1ed1i n\u0103m 2005, trong khi thi\u1ebft k\u1ebf d\u00e2y Linox, th\u1ebf h\u1ec7 d\u00e2y sau, nh\u00f3m k\u1ef9 s\u01b0 thi\u1ebft k\u1ebf c\u00f3 th\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1eddng k\u00ednh 7,8F v\u00e0 gi\u1eed l\u1edbp<img decoding=\"async\" src=\"\/NVUImage\/LinoxKentroxComp.jpg\" alt=\"Linox Kentrox Comparision\" \/>\u00a0c\u00e1ch \u0111i\u1ec7n trong d\u00e2y Linox d\u00e0y b\u1eb1ng trong d\u00e2y Kentrox, 0,28 mm (xem h\u00ecnh b\u00ean ph\u1ea3i). Ho\u1eb7c c\u00f3 th\u1ec3 gi\u1ea3m l\u1edbp c\u00e1ch \u0111i\u1ec7n b\u00ean ngo\u00e0i v\u00e0 b\u00ean trong h\u1ea7u c\u00f3 th\u1ec3 qua m\u1ed9t \u1ed1ng th\u00f4ng 7F. V\u00e0o th\u1eddi \u0111i\u1ec3m \u0111\u00f3 Cty Medtronic c\u00f3 d\u00e2y Sprint Fidelis c\u00f3 th\u1ec3 \u0111\u01b0a qua \u1ed1ng th\u00f4ng 7F, \u0111\u01b0\u1ee3c gi\u1edbi tim m\u1ea1ch khen l\u00e0 d\u00e2y t\u1ed1t\u00a0<img decoding=\"async\" src=\"\/NVUImage\/LinoxThickness.jpg\" alt=\"Linox comparison\" \/>(b\u1ecb recall, thu<br \/>h\u1ed3i,n\u0103m 2007 v\u00ec thi\u1ebft k\u1ebf kh\u00f4ng chu\u1ea9n ). H\u00ecnh b\u00ean ph\u1ea3i t\u1eeb Bs Ip (MSU). D\u00e2y Riata (8F) \u0111ang \u0111\u01b0\u1ee3c cung c\u1ea5p v\u00e0o th\u1eddi \u0111i\u1ec3m \u0111\u00f3 c\u00f3 l\u1edbp c\u00e1ch \u0111i\u1ec7n d\u00e0y 0,09mm v\u00e0 0,15 mm. N\u1ebfu d\u00f9ng l\u1edbp c\u00e1ch \u0111i\u1ec7n nh\u01b0 d\u00e2y Riata, th\u00ec \u0111\u01b0\u1eddng k\u00ednh d\u00e2y Linox c\u00f3 th\u1ec3 gi\u1ea3m 2x 0,19 mm, v\u00e0 d\u00e2y Linox n\u00e0y s\u1ebd \u0111\u1ea1t \u0111\u01b0\u1eddng k\u00ednh 6,7F, c\u00f3 th\u1ec3 qua \u1ed1ng th\u00f4ng\u00a07F d\u1ec5 d\u00e0ng. D\u00e2y St Jude Riata \u0111\u00e3 l\u01b0u h\u00e0nh t\u1eeb n\u0103m 2003 v\u00e0 \u0111\u01b0\u1ee3c xem l\u00e0 m\u1ed9t d\u00e2y \u0111i\u1ec7n c\u1ef1c an to\u00e0n (nh\u01b0ng \u0111\u1ebfn\u00a0<a href=\"https:\/\/systolicvn.com\/Riata.html\">n\u0103m 2010 th\u00ec b\u1ecb ng\u01b0ng cung c\u1ea5p<\/a>, v\u00e0 n\u0103m 2011 b\u1ecb recall v\u00ec s\u1ef1 c\u1ed1 d\u00e2y \u0111\u1ed3ng l\u00f2i ra). V\u00ec mu\u1ed1n \u0111\u1ea1t an to\u00e0n t\u1ed1i \u0111a, nh\u00f3m thi\u1ebft k\u1ebf \u0111\u00e3 quy\u1ebft \u0111\u1ecbnh kh\u00f4ng thay \u0111\u1ed5i l\u1edbp c\u00e1ch \u0111i\u1ec7n b\u00ean ngo\u00e0i, ti\u1ebfp t\u1ee5c d\u00f9ng l\u1edbp c\u00e1ch \u0111i\u1ec7n d\u00e0y 0,28 mm. \u1ede m\u1ed9t c\u00f4ng ty M\u1ef9, ch\u00fang t\u00f4i ch\u1eafc ch\u1eafn l\u00e0 nh\u00f3m Marketing \u0111\u00e3 \u0111\u00f2i h\u1ecfi c\u00e1c k\u1ef9 s\u1ef1 \u0111\u1ea1t \u0111\u01b0\u1eddng k\u00ednh &lt;7F \u0111\u1ec3 c\u00f3 th\u1ec3 c\u1ea1nh tranh v\u1edbi d\u00e2y Sprint Fidelis 7F v\u00e0 d\u00e2y Riata ST 7F s\u1eafp s\u1eeda \u0111\u01b0\u1ee3c Cty St Jude gi\u1edbi thi\u1ec7u (d\u00e2y Riata ST b\u1eb3t \u0111\u1ea7u l\u01b0u h\u00e0nh n\u0103m 2006, c\u0169ng b\u1ecb ng\u01b0ng cung c\u1ea5p n\u0103m 2010 v\u00e0 recall n\u0103m 2011, c\u00f9ng v\u1edbi d\u00e2y Riata).<\/li>\n<\/ul>\n\n\n\n<p>T\u00f3m l\u1ea1i truy\u1ec1n th\u1ed1ng an to\u00e0n BN tr\u00ean h\u1ebft v\u00e0 truy\u1ec1n th\u1ed1ng \u0111\u1ec3 c\u00e1c k\u1ef9 s\u01b0 quy\u1ebft \u0111\u1ecbnh v\u1edbi s\u1ef1 g\u00f3p \u00fd c\u1ee7a Marketing, thay v\u00ec truy\u1ec1n th\u1ed1ng Marketing \u1edf v\u1ecb tr\u00ed l\u00e3nh \u0111\u1ea1o nh\u01b0 \u1edf c\u00e1c c\u00f4ng ty M\u1ef9, \u0111\u00e3 gi\u00fap Cty Biotronik \u0111\u1ea1t m\u1ee9c an to\u00e0n cao nh\u1ea5t trong c\u00e1c c\u00f4ng ty m\u00e1y t\u1ea1o nh\u1ecbp!<\/p>\n\n\n\n<p>Do \u0111\u00f3 b\u1ea1n c\u00f3 th\u1ec3 an t\u00e2m khi d\u00f9ng c\u00e1c thi\u1ebft b\u1ecb Biotronik!<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>\u0110i\u1ec1u m\u00e0 kh\u00f4ng c\u00f3 c\u00f4ng ty m\u00e1y t\u1ea1o nh\u1ecbp (v\u00e0 m\u00e1y ph\u00e1 rung, m\u00e1y \u0111i\u1ec1u tr\u1ecb suy tim) n\u00e0o ph\u1ee7 nh\u1eadn l\u00e0 Cty Biotronik l\u00e0 c\u00f4ng ty \u0111\u00e3 \u0111\u1ea1t m\u1ee9c an to\u00e0n cao nh\u1ea5t, \u0111\u00e3 kh\u00f4ng c\u00f3 b\u1ea5t c\u1ee9 FDA recall n\u00e0o trong v\u00f2ng 10 n\u0103m nay. Trong\u00a0th\u1eddi gian n\u00e0yCty Medtronic n\u0103m 2007 b\u1ecb c\u01a1 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"zakra_page_container_layout":"customizer","zakra_page_sidebar_layout":"customizer","zakra_remove_content_margin":false,"zakra_sidebar":"customizer","zakra_transparent_header":"customizer","zakra_logo":0,"zakra_main_header_style":"default","zakra_menu_item_color":"","zakra_menu_item_hover_color":"","zakra_menu_item_active_color":"","zakra_menu_active_style":"","zakra_page_header":true,"footnotes":""},"categories":[33],"tags":[],"class_list":["post-1690","post","type-post","status-publish","format-standard","hentry","category-huong-dan-cho-benh-nhan"],"_links":{"self":[{"href":"https:\/\/tamthuvn.com\/en\/wp-json\/wp\/v2\/posts\/1690","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/tamthuvn.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tamthuvn.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tamthuvn.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/tamthuvn.com\/en\/wp-json\/wp\/v2\/comments?post=1690"}],"version-history":[{"count":5,"href":"https:\/\/tamthuvn.com\/en\/wp-json\/wp\/v2\/posts\/1690\/revisions"}],"predecessor-version":[{"id":1933,"href":"https:\/\/tamthuvn.com\/en\/wp-json\/wp\/v2\/posts\/1690\/revisions\/1933"}],"wp:attachment":[{"href":"https:\/\/tamthuvn.com\/en\/wp-json\/wp\/v2\/media?parent=1690"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tamthuvn.com\/en\/wp-json\/wp\/v2\/categories?post=1690"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tamthuvn.com\/en\/wp-json\/wp\/v2\/tags?post=1690"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}