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医疗器械媒体报道先锋
分享专业医疗器械知识
来源
:医疗器械创新网
3月21日,强生医疗 (Johnson & Johnson MedTech) 的 Abiomed 部门再次发生严重召回事件,FDA 已将其确定为 I 级召回,即最严重的召回类型,表明使用这些设备可能会导致严重伤害或死亡。涉及到微型 Impella 心脏泵系列产品,此前有报道称该设备在操作过程中可能会刺穿和切穿左心室壁。
01
已致129人重伤,其中49人死亡
FDA本周报告称,在 129 份重伤记录中,有 49 名患者因该问题死亡。
强生 (J&J) 的 Abiomed 此前于 12 月底向医疗保健提供者发出了一封紧急医疗设备更正函,通知医疗保健提供者存在风险,此次召回涉及 Impella 泵各类型号中的 66,390 台设备。FDA 于 3 月 20 日向该企业发起一级召回,这是该机构最严重的召回指定,但是,没有任何设备部件被认为有缺陷,也不需要退回给制造商。
Impella装置示意图
Impella 左侧血泵用于在称为经皮冠状动脉介入治疗 (PCI) 的高风险导管手术期间为心脏(心室)的泵室提供短期支持。当严重心脏病发作(急性心肌梗塞)、心脏直视手术后 48 小时内发生持续心源性休克,或者由于心肌病导致心脏功能不良时,也可使用 Impella 左侧血泵。Impella 疗法旨在减少心室的工作并为循环系统提供支持,以便心脏有时间恢复。Impella 泵有多种类型,用于不同的治疗目的。
召回原因
Abiomed 正在召回其 Impella 左侧血泵,在手术过程中,Impella 装置泵导管可能会刺穿(切割)心脏左心室壁。
使用受影响的 Impella 泵可能会导致严重的不良健康后果,包括左心室穿孔或游离壁破裂、高血压、血流不足和死亡。
相反,根据 FDA 的召回公告,该公司和该机构已更新了设备使用说明(IFU)中对外科医生的警告,以强调“由于操作员操作”而存在穿孔的潜在风险。
解决方案
强生医疗在给媒体的一份声明中表示:“出于对患者安全的考虑,我们的 IFU 已更新,提供了有关植入和重新定位的更强有力的技术指导,并强调植入 Impella 时要考虑特定的心脏和外周血管解剖学因素。” “此通知并非设备移除,Impella 心脏泵仍留在市场上并可供患者使用。”
此外,FDA 敦促用户在推进或扭转泵导管时采用成像辅助系统,并表示具有特定风险的人可能包括女性、老年人和既往有过前壁梗死史的人,或者在接受手术后最靠近胸部前部的疤痕心脏组织的人群要特别注意。该机构还表示,在对植入患者进行心肺复苏胸部按压时应尤为小心。
侵入性较小的泵通过血管蜿蜒进入心室,内部装有旋转叶轮,可将血液压入主动脉,从而减轻衰弱的心肌的部分工作量。
02
曾被两次一级召回
△Impella®系列心脏泵
2023年7月,Impella又一次被美国药监局一级召回。原因是:对于实施过经导管主动脉置换手术(TAVR)的患者,Impella的旋转叶轮存在与TAVR植入物(远端支架)碰撞的风险,碰撞可能损坏或毁坏叶轮叶片。受损的叶轮系统可能减少血流量或停止心脏泵的运行,从而延误治疗或无法为患者提供足够的血流量支持。对于需要高水平支持的患者而言,没有足够的血流量支持,可能会危及生命。另一风险是破碎的叶片碎片可能流入血管系统,引发栓塞。
该公司敦促外科医生在调整其在心脏内的位置之前确保该装置已停止。FDA随后报告了与该问题相关的四例死亡事件。
2023年6月,FDA曾对Impella 5.5发起过另一级召回涉及466台设备,该款产品是右侧泵(带有 SmartAssist 的 Impella RP Flex),召回原因是灌注液泄漏导致灌注压降低,引起设备警报。此前更新说明澄清了患者的抗凝凝血时间低于建议的情况。这些患者可能面临血栓形成或颗粒沉积物堆积的风险;FDA 报告了与此次召回相关的 12 起受伤事件。
2022年12月22日,全球医疗巨头强生公司宣布已完成对Abiomed,Inc.的收购,总收购金额约166亿美元。
Abiomed成立于1981年,总部位于美国马萨诸塞州,是提供循环支持和充氧的医疗设备的领先提供商,也是全球心室辅助血泵(VAD)领域佼佼者,其生产的Impella心脏泵,是唯一获得美国 FDA 批准适用于需要高危 PCI 或 AMI 心源性休克等严重冠状动脉疾病患者的经皮心脏泵技术。目前全球使用Impella心脏泵的患者超过15万。
在全球市场,受限于介入式人工心脏的高技术门槛,仅有少数企业布局,而且Impella是目前唯一获得美国FDA批准的经皮心脏泵技术(PVAD),其他企业的介入式人工心脏还处于研发或临床注册阶段。
03
庞大的患者需求
孕育出下一个大蓝海
心衰的危害性及庞大的患者数孕育出了“下一个蓝海”。心力衰竭,五年死亡率高达30-70%,被称为“心血管病领域最后的战场”。
根据公开数据,全球心衰患者近3000万,我国心衰患者约有1067万。预计随着心脏疾病患者的生存期延长、老龄化程度加深,心衰患者数量将持续增长。心脏辅助装置(VAD)已逐渐成为治疗终末期心衰的重要手段。
市场研究机构ReportLinker发布的数据显示:全球心衰治疗器械市场预计于2025年达到140亿美元;中国心衰管理市场规模将超百亿。
国内介入人工心脏崛起
介入式人工心脏毫无疑问是高技术、高门槛赛道,但国内仍有一批创新企业布局。其中,永仁心、苏州同心、心擎医疗、航天泰心、心恒睿医疗、核心医疗、通灵仿生、心岭迈德、生命盾医疗、晟视科技、心擎医疗、丰凯医疗等企业积极布局。
2024年2月,永仁心医疗推出新一代人工心脏产品EVA-Pulsar™左心室辅助装置正式获得NMPA医疗器械注册证,成为国内第五款上市人工心脏,这标志着永仁心医疗率先完成产品迭代,手握国内唯二两款长期型人工心脏血液泵。
其余四款获批产品分别为:永仁心医疗(EVAHEART I)、同心医疗(CH-VAD)、航天泰心(HeartCon)、核心医疗(Corheart6)。
尽管心室辅助的长期植入需求巨大,但目前国内外获批长期植入的LVAD寥寥无几。在中国,目前仅有永仁心的EVAHEART 1和EVA-Pulsar™获批长期使用。2022年的商业植入市场份额位居第一,遥遥领先其他同类产品。在美国,仅有一款Heartmate3获批长期使用,其他第三代磁悬浮、磁液悬浮等产品均未获批长期植入。
心脏作为生命的动力源泉,其健康状况直接关联到生命的质量。心力衰竭,作为多种心血管疾病的最终表现形态,其患病率、发病率及死亡率均呈逐年上升趋势,已成为当前心血管疾病领域的重大挑战。在人工心脏技术的发展中,介入式人工心脏展现出巨大的应用潜力,有望成为下一阶段的研究热点。展望未来十年,心衰器械领域将迎来发展的黄金时期。我们期待国内医工转化速度能够加快,为心力衰竭治疗带来更多的创新解决方案。
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rgba(16, 174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media screen and (min-width:1024px){body:not(.pages_skin_pc) .wx-root,body:not(.pages_skin_pc) body{--appmsgExtra-BG: #F7F7F7}}@media screen and (min-width:1024px){body:not(.pages_skin_pc) .wx-root[data-weui-theme=dark],body:not(.pages_skin_pc) body[data-weui-theme=dark]{--weui-BG-0: #111;--weui-BG-1: #1e1e1e;--weui-BG-2: #191919;--weui-BG-3: #202020;--weui-BG-4: #404040;--weui-BG-5: #2c2c2c;--weui-FG-0: rgba(255, 255, 255, .8);--weui-FG-HALF: rgba(255, 255, 255, .6);--weui-FG-1: rgba(255, 255, 255, .5);--weui-FG-2: rgba(255, 255, 255, .3);--weui-FG-3: rgba(255, 255, 255, .1);--weui-FG-4: rgba(255, 255, 255, .15);--weui-FG-5: rgba(255, 255, 255, .1);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #c87d2f;--weui-YELLOW: #cc9c00;--weui-GREEN: #74a800;--weui-LIGHTGREEN: #3eb575;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1196ff;--weui-PURPLE: #8183ff;--weui-WHITE: rgba(255, 255, 255, .8);--weui-LINK: #7d90a9;--weui-TEXTGREEN: #259c5c;--weui-FG: #fff;--weui-BG: #000;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: rgba(250, 157, 59, .6);--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: rgba(6, 174, 86, .6);--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: rgba(16, 174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media screen and (min-width:1024px){body:not(.pages_skin_pc) .wx-root[data-weui-theme=dark],body:not(.pages_skin_pc) body[data-weui-theme=dark]{--appmsgExtra-BG: #121212}}@media screen and (min-width:1024px){body:not(.pages_skin_pc)body:not(.pages_skin_pc){background:var(--weui-BG-2)}}@media screen and (min-width:1024px) and (prefers-color-scheme:dark){body:not(.pages_skin_pc) .wx-root[data-weui-mode=care]:not([data-weui-theme=light]),body:not(.pages_skin_pc) body[data-weui-mode=care]:not([data-weui-theme=light]){--weui-BG-0: #111;--weui-BG-1: #1e1e1e;--weui-BG-2: #191919;--weui-BG-3: #202020;--weui-BG-4: #404040;--weui-BG-5: #2c2c2c;--weui-FG-0: rgba(255, 255, 255, .85);--weui-FG-HALF: rgba(255, 255, 255, .65);--weui-FG-1: rgba(255, 255, 255, .55);--weui-FG-2: rgba(255, 255, 255, .35);--weui-FG-3: rgba(255, 255, 255, .1);--weui-FG-4: rgba(255, 255, 255, .15);--weui-FG-5: rgba(255, 255, 255, .1);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #c87d2f;--weui-YELLOW: #cc9c00;--weui-GREEN: #74a800;--weui-LIGHTGREEN: #3eb575;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1196ff;--weui-PURPLE: #8183ff;--weui-WHITE: rgba(255, 255, 255, .8);--weui-LINK: #7d90a9;--weui-TEXTGREEN: #259c5c;--weui-FG: #fff;--weui-BG: #000;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: rgba(250, 157, 59, .6);--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: rgba(6, 174, 86, .6);--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: rgba(16, 174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media screen and (min-width:1024px) and (prefers-color-scheme:dark){body:not(.pages_skin_pc) .wx-root:not([data-weui-theme=light]),body:not(.pages_skin_pc) body:not([data-weui-theme=light]){--weui-BG-0: #111;--weui-BG-1: #1e1e1e;--weui-BG-2: #191919;--weui-BG-3: #202020;--weui-BG-4: #404040;--weui-BG-5: #2c2c2c;--weui-FG-0: rgba(255, 255, 255, .8);--weui-FG-HALF: rgba(255, 255, 255, .6);--weui-FG-1: rgba(255, 255, 255, .5);--weui-FG-2: rgba(255, 255, 255, .3);--weui-FG-3: rgba(255, 255, 255, .1);--weui-FG-4: rgba(255, 255, 255, .15);--weui-FG-5: rgba(255, 255, 255, .1);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #c87d2f;--weui-YELLOW: #cc9c00;--weui-GREEN: #74a800;--weui-LIGHTGREEN: #3eb575;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1196ff;--weui-PURPLE: #8183ff;--weui-WHITE: rgba(255, 255, 255, .8);--weui-LINK: #7d90a9;--weui-TEXTGREEN: #259c5c;--weui-FG: #fff;--weui-BG: #000;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: rgba(250, 157, 59, .6);--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: rgba(6, 174, 86, .6);--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: rgba(16, 174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media screen and (min-width:1024px) and (prefers-color-scheme:dark){body:not(.pages_skin_pc) 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59, .6);--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: rgba(6, 174, 86, .6);--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: rgba(16, 174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--discussInput-BG: rgba(255, 255, 255, .03)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--nickName-FG: #959595}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--weui-BG-0: #111;--weui-BG-1: #1e1e1e;--weui-BG-2: #191919;--weui-BG-3: #202020;--weui-BG-4: #404040;--weui-BG-5: #2c2c2c;--weui-FG-0: rgba(255, 255, 255, .8);--weui-FG-HALF: rgba(255, 255, 255, .6);--weui-FG-1: rgba(255, 255, 255, .5);--weui-FG-2: rgba(255, 255, 255, .3);--weui-FG-3: rgba(255, 255, 255, .1);--weui-FG-4: rgba(255, 255, 255, .15);--weui-FG-5: rgba(255, 255, 255, .1);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #c87d2f;--weui-YELLOW: #cc9c00;--weui-GREEN: #74a800;--weui-LIGHTGREEN: #3eb575;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1196ff;--weui-PURPLE: #8183ff;--weui-WHITE: rgba(255, 255, 255, .8);--weui-LINK: #7d90a9;--weui-TEXTGREEN: #259c5c;--weui-FG: #fff;--weui-BG: #000;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: rgba(250, 157, 59, .6);--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: rgba(6, 174, 86, .6);--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: rgba(16, 174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--appmsgExtra-BG: #121212}}h1,h2,h3,h4,h5,h6{font-weight:400;font-size:16px}@media screen and (min-width:1024px){body:not(.pages_skin_pc) :root{--appmsgPageGap: 20px;--appmsgPageBottomGap: 40px}}:root{--articleFontsize: 17px}:root{--sab: env(safe-area-inset-bottom)}:root{--wxBorderAvatarRatio: 3}:root{--discussPageGap: 20px}:root{--immersive-safe-bottom: env(safe-area-inset-bottom)}:root{--appmsgPageGap: 20px;--appmsgPageBottomGap: 40px}*{margin:0;padding:0}.rich_media_content *{max-width:100%!important;box-sizing:border-box!important;-webkit-box-sizing:border-box!important;word-wrap:break-word!important}.rich_media_content p{clear:both;min-height:1em}td p{margin:0;padding:0}@media(prefers-color-scheme:dark){body:not([data-weui-theme=light]) .rich_media_content img:not(.wx_img_placeholder){filter:brightness(.8)}}
div.autoTypeSetting24psection > p,div.autoTypeSetting24psection > section{margin-bottom: 24px;}