《颅内动脉瘤手术计划软件获批上市》

  • 来源专题:生物安全知识资源中心—领域情报网
  • 编译者: hujm
  • 发布时间:2022-10-12
  •   近日,国家药品监督管理局经审查,批准了强联智创(北京)科技有限公司生产的“颅内动脉瘤手术计划软件”创新产品注册申请。

      该产品由应用程序和授权文件组成,软件功能模块包括数据加载、显示交互、数据管理、数据处理和日志。产品用于脑血管病患者X射线血管造影三维体层图像的显示、分割、测量和处理,辅助医生在神经介入手术时进行动脉瘤弹簧圈栓塞用的微导管路径和塑形规划。

      该产品利用医学图像处理技术对颅内动脉瘤患者的X射线血管造影三维体层图像进行处理,实现三维血管重建、动脉瘤分割和自动测量及微导管路径和塑形针形状规划,帮助医生进行术前方案规划。与传统神经介入手术方式相比,该产品可以提升微导管一次性到位率,缩短微导管输送时间,降低术中微导管反复推送对血管刺激导致的并发症发生概率,减少医生、患者X射线辐射时间。

      药品监督管理部门将加强该产品上市后监管,保护患者用械安全。

  • 原文来源:https://www.nmpa.gov.cn/yaowen/ypjgyw/20221011145912169.html
相关报告
  • 《颅内取栓支架获批上市》

    • 来源专题:生物安全知识资源中心—领域情报网
    • 编译者:hujm
    • 发布时间:2023-08-21
    •   近日,国家药品监督管理局批准了急速医疗有限公司Rapid Medical Ltd.生产的颅内取栓支架创新产品注册申请。   该产品由头端、丝网、推送轴、控制丝和手柄组成,与国内外已上市同类产品相比,其可控膨胀技术为国际首创。在手术过程中,医生能实时控制该产品的膨胀程度和施加在血管与血栓上的径向力大小,使其安全输送至病变部位,释放过程更加精准,增加取栓成功率;回撤时,医生也可对该产品进行适度收缩,降低径向力从而减少对敏感脆弱血管壁的扰动和损伤。该产品预期可提高急性缺血性脑卒中患者的术后血管再通率,提高患者生活质量。    药品监督管理部门将加强该产品上市后监管,保护患者用械安全。
  • 《腹主动脉瘤的更新指南》

    • 来源专题:心血管疾病防治
    • 编译者:张燕舞
    • 发布时间:2018-05-22
    • 2018年2月,美国血管外科学会(SVS)发布了关于腹主动脉瘤(AAA)患者护理的最新指南。 与先前指南的主要区别包括较长的超声监视小AAA的间隔时间,使用血管质量计划围手术期死亡风险评分来辅助选择性AAA的决策制定,并且当解剖学适合时,血管内而不是开放性AAA破裂修复,包括快速 如果急诊科能够在90分钟内完成手术干预,则转移至血管中心。 我们的建议与这些修订是一致的。 BACKGROUND Decision-making related to the care of patients with an abdominal aortic aneurysm (AAA) is complex. Aneurysms present with varying risks of rupture, and patient-specific factors influence anticipated life expectancy, operative risk, and need to intervene. Careful attention to the choice of operative strategy along with optimal treatment of medical comorbidities is critical to achieving excellent outcomes. Moreover, appropriate postoperative surveillance is necessary to minimize subsequent aneurysm-related death or morbidity. METHODS The committee made specific practice recommendations using the Grading of Recommendations Assessment, Development, and Evaluation system. Three systematic reviews were conducted to support this guideline. Two focused on evaluating the best modalities and optimal frequency for surveillance after endovascular aneurysm repair (EVAR). A third focused on identifying the best available evidence on the diagnosis and management of AAA. Specific areas of focus included (1) general approach to the patient, (2) treatment of the patient with an AAA, (3) anesthetic considerations and perioperative management, (4) postoperative and long-term management, and (5) cost and economic considerations. RESULTS Along with providing guidance regarding the management of patients throughout the continuum of care, we have revised a number of prior recommendations and addressed a number of new areas of significance. New guidelines are provided for the surveillance of patients with an AAA, including recommended surveillance imaging at 12-month intervals for patients with an AAA of 4.0 to 4.9 cm in diameter. We recommend endovascular repair as the preferred method of treatment for ruptured aneurysms. Incorporating knowledge gained through the Vascular Quality Initiative and other regional quality collaboratives, we suggest that the Vascular Quality Initiative mortality risk score be used for mutual decision-making with patients considering aneurysm repair. We also suggest that elective EVAR be limited to hospitals with a documented mortality and conversion rate to open surgical repair of 2% or less and that perform at least 10 EVAR cases each year. We also suggest that elective open aneurysm repair be limited to hospitals with a documented mortality of 5% or less and that perform at least 10 open aortic operations of any type each year. To encourage the development of effective systems of care that would lead to improved outcomes for those patients undergoing emergent repair, we suggest a door-to-intervention time of <90 minutes, based on a framework of 30-30-30 minutes, for the management of the patient with a ruptured aneurysm. We recommend treatment of type I and III endoleaks as well as of type II endoleaks with aneurysm expansion but recommend continued surveillance of type II endoleaks not associated with aneurysm expansion. Whereas antibiotic prophylaxis is recommended for patients with an aortic prosthesis before any dental procedure involving the manipulation of the gingival or periapical region of teeth or perforation of the oral mucosa, antibiotic prophylaxis is not recommended before respiratory tract procedures, gastrointestinal or genitourinary procedures, and dermatologic or musculoskeletal procedures unless the potential for infection exists or the patient is immunocompromised. Increased utilization of color duplex ultrasound is suggested for postoperative surveillance after EVAR in the absence of endoleak or aneurysm expansion. CONCLUSIONS Important new recommendations are provided for the care of patients with an AAA, including suggestions to improve mutual decision-making between the treating physician and the patients and their families as well as a number of new strategies to enhance perioperative outcomes for patients undergoing elective and emergent repair. Areas of uncertainty are highlighted that would benefit from further investigation in addition to existing limitations in diagnostic tests, pharmacologic agents, intraoperative tools, and devices.