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Imperative Care

紧急护理

, Inc.

，公司。

today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s Zoom System, making it the first comprehensive stroke thrombectomy system to include large-bore .088” catheters indicated for both access and aspiration when used with a Zoom Catheter. This clearance expands Imperative Care's current portfolio of .035” - .071” aspiration catheters to now include the Zoom .088” catheters – Zoom 88, Zoom 88 Support and TracStar – for aspiration as part of the Zoom System..

今天宣布，该公司已获得美国食品和药物管理局（FDA）510（k）对该公司Zoom系统的许可，这使其成为第一个全面的中风血栓切除系统，其中包括大口径0.088“导管，当与Zoom导管一起使用时，可用于进入和抽吸。这一许可扩大了必应护理目前0.035“-0.071”抽吸导管的组合，现在包括Zoom 0.088”导管–Zoom 88、Zoom 88 Support和TracStar–作为Zoom系统的一部分用于抽吸。。

Clinical evidence submitted to the FDA to support the clearance included final data from the

提交给FDA以支持清除的临床证据包括来自

Imperative Trial

强制审判

. This prospective, multi-center clinical trial evaluated the clinical benefits of the Zoom System in patients treated across 26 U.S. institutions. The analyzed cohort included 211 patients who were treated with concomitant aspiration thrombectomy using two catheters.

这项前瞻性多中心临床试验评估了Zoom系统在26家美国机构治疗的患者中的临床益处。分析的队列包括211名使用两个导管同时进行抽吸血栓切除术的患者。

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At Imperative Care, we are focused on developing a patient-centric and well-studied comprehensive stroke system for physicians to best care for their patients based on their specific needs and anatomy,” said Ariel Sutton, Executive Vice President and General Manager of Imperative Care’s Stroke business.

在紧急护理公司，我们专注于为医生开发一个以患者为中心且经过充分研究的综合卒中系统，以根据患者的具体需求和解剖结构为患者提供最佳护理，”紧急护理公司卒中业务执行副总裁兼总经理Ariel Sutton说。

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We know that with stroke, time is the most critical factor in driving positive patient outcomes. The Zoom System is the first purpose-built technology from access to aspiration that maximizes versatility for rapid and effective procedures as validated by the Imperative Trial and previous clinical studies of the Zoom Stroke Solution.

。Zoom系统是第一个从获取到抽吸的专门构建技术，它最大程度地提高了快速有效程序的多功能性，这已通过强制性试验和Zoom Stroke解决方案的先前临床研究得到验证。

Thank you to all the physicians, patients and their families who participated in this landmark trial and placed their trust in our technology.”.

感谢所有参与这项具有里程碑意义的试验并信任我们技术的医生，患者及其家属。”。

Key results from the Imperative Trial submitted to the FDA to support clearance demonstrated:

提交给FDA以支持批准的强制性试验的关键结果表明：

Median time from groin puncture to mTICI ≥2B reperfusion of 19 minutes, fastest among the referenced thrombectomy trials.

从腹股沟穿刺到mTICI≥2B再灌注的中位时间为19分钟，在参考血栓切除术试验中最快。

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A core-lab adjudicated rate of mTICI ≥2B reperfusion was achieved in 84% of patients within 3 passes or less without the use of any additional thrombectomy devices as rescue therapy, similar to prior trials (82%).

与之前的试验（82%）相似，84%的患者在3次通过或更少的时间内达到了核心实验室判定的mTICI≥2B再灌注率，而不使用任何额外的血栓切除装置作为抢救治疗。

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Stent retriever rescue therapy used in only 4.7% of cases to achieve mTICI ≥2B reperfusion.

支架回收器抢救治疗仅用于4.7%的病例，以实现mTICI≥2B再灌注。

A core-lab adjudicated rate of symptomatic intracranial hemorrhage of 0.9%, lower than the rate of prior trials (4.7%,)

核心实验室判定的症状性颅内出血率为0.9%，低于之前的试验率（4.7%）

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, and a rate of independently adjudicated dissection and vessel perforation of 0.5%, lower than prior trials (1.3%).

，独立判定的解剖和血管穿孔率为0.5%，低于之前的试验（1.3%）。

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In addition to the remarkable efficacy of the Zoom System, I was impressed by the demonstrated safety profile as evidenced by a 0.5% instance of serious vessel injury reported in the study. Even more impressive was the 0.9% rate of symptomatic intracranial hemorrhage,” said Dr. William Mack, M.D., Professor of Neurosurgery at the Keck School of Medicine, University of Southern California and Co-Principal Investigator of the Imperative Trial.

除了Zoom系统的显着功效外，我还对所证明的安全性印象深刻，研究中报告的0.5%严重血管损伤实例证明了这一点。更令人印象深刻的是症状性颅内出血的发生率为0.9%，”南加州大学凯克医学院神经外科教授、PRISTIVE试验联合首席研究员William Mack博士说。

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These data, combined with our extensive experience with the Zoom System, reinforce our confidence in the technology and its clinical benefits for our practice and the patients we treat.”

这些数据，再加上我们在Zoom系统方面的丰富经验，增强了我们对该技术及其对我们的实践和我们治疗的患者的临床益处的信心。”

About the Zoom Stroke Solution

关于缩放笔划解决方案

The Zoom Stroke Solution is a complete stroke system from access through reperfusion designed for fast and effective clot removal in patients presenting with acute ischemic stroke. The comprehensive system includes the Zoom 6F Insert Catheters, Zoom 88 and Zoom 88 Support Large Distal Platform, and Zoom RDL Radial Access Platform, the Zoom 35, 45, 55 and 71 Catheters, Zoom Pump, Zoom POD and accessories.

Zoom Stroke解决方案是一个完整的中风系统，从进入到再灌注，旨在快速有效地清除急性缺血性中风患者的血块。综合系统包括Zoom 6F插入导管、Zoom 88和Zoom 88支撑大远端平台、Zoom RDL径向通路平台、Zoom 35、45、55和71导管、Zoom泵、Zoom POD和附件。

All Zoom Catheters are designed with the unique TRX™ Tip, which provides 15% greater clot engagement area at the tip of the catheter.

所有Zoom导管均设计有独特的TRX™尖端，可在导管尖端提供15%的凝块接合面积。

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and are designed to enable smooth tracking through challenging vasculature. For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit:

并且旨在通过具有挑战性的脉管系统实现平滑跟踪。有关完整的产品信息，包括适应症、禁忌症、警告、预防措施和不良事件，请访问：

https://bit.ly/3yWkfEJ

https://bit.ly/3yWkfEJ

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About Imperative Care, Inc.

关于紧急护理公司。

Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for people affected by devastating vascular diseases such as stroke and pulmonary embolism. The company is focused on addressing specific gaps in treatment and care to make an impact across the entire patient journey.

强制护理是一家商业化的医疗技术公司，研究和开发相关创新，以提高对中风和肺栓塞等破坏性血管疾病患者的护理水平。该公司专注于解决治疗和护理方面的具体差距，以在整个患者旅程中产生影响。

Imperative Care is based in Campbell, Calif. .

紧急护理总部位于加利福尼亚州坎贝尔。

https://imperativecare.com

https://imperativecare.com

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1. Meta-Analysis of 510(k) data from ARISE II, TIGER, Penumbra 3D, and PROST trials. Data on file.

1.ARISE II，TIGER，Penumbra 3D和PROST试验的510（k）数据的荟萃分析。文件中的数据。

2. Meta-Analysis of 510(k) data from SWIFT PRIME, Penumbra 3D, ARISE II, TIGER, ETIS, and PROST trials. Data on file.

。文件中的数据。

3. Meta-Analysis of SWIFT PRIME, MR CLEAN De Novo 510(k) data, Penumbra 3D, ARISE II, and ETIS. Data on file.

3.SWIFT PRIME，MR CLEAN De Novo 510（k）数据，半影3D，ARISE II和ETIS的荟萃分析。文件中的数据。

4. Meta-Analysis of SWIFT PRIME, MR CLEAN De Novo 510(k) data, Penumbra 3D, ARISE II, and PROST. Data on file.

4.SWIFT PRIME，MR CLEAN De Novo 510（k）数据，半影3D，ARISE II和PROST的荟萃分析。文件中的数据。

5. 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.

5.Vargas J，Blalock J，Venkatraman A等。斜尖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。