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Imperative Care has released promising data from the Neurovascular Quality Initiative-Quality Outcome Database (NVQI-QOD) evaluating the Zoom Stroke Solution.
Imperative Care已经从评估Zoom-Stroke解决方案的神经血管质量倡议质量结果数据库(NVQI-QOD)发布了有希望的数据。
The NVQI-QOD is a registry developed by SNIS through its Patient Safety Organization (PSO), along with the NeuroPoint Alliance of the American Association of Neurological Surgeons (AANS) and Society of Vascular and Interventional Neurology (SVIN). The primary goals of the NVQI-QOD registry are to provide a platform for driving improvement in stroke care while meeting the demands set by regulatory agencies and evaluating the safety and clinical performance of medical devices used in treatment of acute ischemic stroke. .
NVQI-QOD是SNIS通过其患者安全组织(PSO)以及美国神经外科医师协会(AANS)和血管和介入神经病学协会(SVIN)的神经点联盟开发的注册中心。NVQI-QOD登记处的主要目标是提供一个平台,推动中风护理的改善,同时满足监管机构的要求,评估用于治疗急性缺血性中风的医疗器械的安全性和临床表现。。.
“We are excited about the opportunity to collaborate with NVQI-QOD to reinforce the safety and effectiveness of our unique angled-tip aspiration catheters for treating patients with ischemic stroke,” said Ariel Sutton, general manager of Imperative Care’s Stroke business. “Continuing to add to our growing body of evidence with the Zoom Stroke Solution is a priority for Imperative Care.
Imperative Care中风业务总经理Ariel Sutton说:“我们很高兴有机会与NVQI-QOD合作,加强我们独特的倾斜尖端抽吸导管治疗缺血性卒中患者的安全性和有效性。”。“使用Zoom Stroke解决方案继续增加我们越来越多的证据是当务之急护理的优先事项。
These data further demonstrate the positive association between the use of the Zoom Aspiration Catheters with procedure times and successful final reperfusion.” .
这些数据进一步证明了使用Zoom抽吸导管与手术时间和成功的最终再灌注之间的正相关性。”。.
The safety and clinical performance data from 211 patients with large or medium sized vessel occlusions who were treated with Zoom Aspiration Catheters were presented by Mahesh Jayaraman, M.D., Brown University. In 67.8% of patients, an aspiration-first technique was used, and in the remaining 32.2% of patients, a combined technique using aspiration with a stent-retriever was used.
布朗大学医学博士Mahesh Jayaraman介绍了211例使用变焦抽吸导管治疗的大中型血管闭塞患者的安全性和临床表现数据。在67.8%的患者中,使用了抽吸优先技术,其余32.2%的患者使用了使用支架回收器抽吸的组合技术。
Adjunctive therapies including intra- or extra-cranial angioplasty and/or stenting was performed in 9% of patients. .
9%的患者进行了包括颅内或颅外血管成形术和/或支架术在内的辅助治疗。。.
Results from the analysis showed that:
分析结果显示:
Median time from arterial puncture to recanalization was 22 minutes.
从动脉穿刺到再通的中位时间为22分钟。
TICI≥2B reperfusion was achieved in 91.9% of patients, and in 59% of patients after the first pass.
TICI≥2B再灌注在91.9%的患者中实现,并且在第一次通过后59%的患者中实现。
Overall, TICI≥2C reperfusion was achieved in 59.2% of patients.
总体而言,59.2%的患者达到TICI≥2C再灌注。
When examining by clot location, rates of final TICI≥2C reperfusion were 53.8% for ICA, 58.7% for M1, 57.4% for M2 and 69.2% for medium vessels.
当通过凝块位置检查时,ICA的最终TICI≥2C再灌注率为53.8%,M1为58.7%,M2为57.4%,中型血管为69.2%。
Among the patients with 90-day follow-up data, 53.2% were functionally independent with Modified Rankin Scale scores of 0-2.
在90天随访数据的患者中,53.2%在功能上独立,改良Rankin量表评分为0-2。
The overall rate of symptomatic intracranial hemorrhage was 2.8%.
症状性颅内出血总发生率为2.8%。
“The angled-tip Zoom Aspiration Catheters have become a valuable tool for stroke thrombectomy procedures due to their proven trackability and ability to engage clot effectively,” Jayaraman stated. “These real-world data demonstrate that treatment with the Zoom Aspiration Catheters led to high rates of successful reperfusion in patients with ischemic stroke, with no safety concerns.
Jayaraman说:“有角度的尖端变焦抽吸导管已经成为中风血栓切除手术的有价值的工具,因为它们具有良好的可追踪性和有效接合凝块的能力。”。“这些真实世界的数据表明,使用Zoom抽吸导管治疗导致缺血性卒中患者再灌注成功率高,没有安全隐患。
We look forward to future NVQI-QOD efforts to analyze valuable real-world data and evaluate the safety and effectiveness of new and promising technologies in the space.” .
我们期待未来的NVQI-QOD努力分析有价值的现实数据,并评估新技术在太空中的安全性和有效性。”。.
The Zoom Stroke Solution is the complete stroke system from access through reperfusion for removing clots in patients suffering from an acute ischemic stroke. The system includes the Zoom 88 Large Distal Platform and Zoom RDL Radial Access Platform for neurovascular access, four vessel-matched Zoom Aspiration Catheters, the Zoom Pump, the Zoom POD and accessories.
变焦中风解决方案是通过再灌注进入的完整中风系统,用于去除患有急性缺血性中风的患者的凝块。该系统包括用于神经血管通路的Zoom 88大型远端平台和Zoom RDL径向通路平台,四个血管匹配变焦抽吸导管,变焦泵,变焦荚和附件。
All Zoom catheters are designed with the TRX Tip which provides 15% greater clot engagement area at the tip of the catheter1 and are designed to enable smooth tracking through challenging vasculature. .
所有变焦导管均设计有TRX尖端,可在导管尖端提供15%更大的凝块接合面积1,旨在通过具有挑战性的脉管系统实现平滑跟踪。 .
“The clinical outcomes from this study are inspiring and prove that the NVQI-QOD registry harbors valuable data which can be leveraged by researchers, FDA regulators, payors, and industry to demonstrate innovative medical devices improve patient outcomes,” said Sameer Ansari, M.D., Ph.D., interventional neuroradiologist at Northwestern Medicine and NVQI-QOD SNIS PSO medical director. .
“这项研究的临床结果令人鼓舞,证明NVQI-QOD注册中心拥有有价值的数据,可供研究人员,FDA监管机构,付款人和行业用来展示创新医疗设备以改善患者预后,”西北医学介入神经放射学家和NVQI-QOD SNIS PSO医疗总监Sameer Ansari博士说。。.
Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for people affected by vascular diseases such as stroke and pulmonary embolism. The company has four businesses focused on addressing specific gaps in treatment and care to make an impact across the entire patient journey.
Imperative Care是一家商业阶段医疗技术公司,致力于研究和开发相关创新,以提升对中风和肺栓塞等血管疾病患者的护理。该公司有四家企业专注于解决治疗和护理方面的具体差距,从而在整个患者旅程中产生影响。
Imperative Care is based in Campbell, Calif. .
必要的护理工作位于加利福尼亚州的坎贝尔。
Reference
参考
1 Vargas J, Blalock J, Venkatraman A, et al Efficacy of beveled tip aspiration catheter in mechanical thrombectomy for acute ischemic stroke Journal of NeuroInterventional Surgery 2021;13:823-826.
1 Vargas J,Blalock J,Venkatraman A,等斜角尖端抽吸导管在急性缺血性卒中机械血栓切除术中的疗效神经介入外科杂志2021;13:823-826.