CAMPBELL, Calif.--(BUSINESS WIRE)--Imperative Care, Inc., today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Zoom™ 6F Insert Catheters, the company’s latest innovation in elevating stroke care and the first insert catheters developed specifically for ischemic stroke procedures.

加利福尼亚州坎贝尔市——（商业新闻短讯）——Imperative Care,今天宣布，美国食品和药物管理局（FDA）510（k）批准其Zoom™6F插入式导管，这是该公司在提升中风护理方面的最新创新，也是第一个专门为缺血性中风手术开发的插入式导管。

The company also announced the successful completion of the first case with the Zoom 6F Insert Catheters, which was performed by Dr. Dana Tomalty at Huntsville Hospital in Huntsville, Alabama..

公司还宣布，阿拉巴马州亨茨维尔市亨茨维尔医院的 Dana Tomalty 医生使用 Zoom 6F 插入导管成功完成了首例手术。

Based on physician feedback, the new Zoom 6F Insert Catheters were developed to be more supportive, more torque-able and longer than current vessel selection devices and are offered in three stroke-specific shapes. These features are designed for faster vessel selection and uncompromised delivery of the company’s comprehensive 0.088” intracranial access technologies – Zoom 88, Zoom 88 Support and Zoom RDL – to the intracranial anatomy..

根据医生的反馈，新型Zoom 6F插入式导管比目前的血管选择装置具有更大的支持力，更大的扭矩和更长的长度，并且具有三种中风特定的形状。这些功能旨在更快地选择血管，并毫不妥协地将公司全面的0.088英寸颅内通路技术（Zoom 88、Zoom 88 Support和Zoom RDL）提供给颅内解剖结构。。

“Insert catheters used for stroke today are diagnostic catheters that were designed for cardiovascular access more than 30 years ago. The Zoom 6F Insert Catheters bring physicians the modern-day tools and technologies that will allow them the opportunity to best care for their patients, bridging the innovation gap of 30 years to today’s standards for stroke treatment,” said Ariel Sutton, General Manager of Imperative Care’s Stroke Business..

“如今用于中风的插入式导管是30多年前为心血管通路设计的诊断导管。Zoom 6F插入式导管为医生带来了现代工具和技术，使他们有机会为患者提供最佳护理，弥补了30年来中风治疗标准的创新差距，”强制性护理中风业务总经理Ariel Sutton说。。

“We are deeply committed to working closely with physicians to identify critical gaps in stroke care and providing innovative solutions that bring meaningful benefits to their patients. The introduction of the Zoom 6F Insert Catheters demonstrates our core tenet of clinical partnership, which puts the perspectives of front-line physicians at the center of our research and development process,” added Sutton..

萨顿补充道：“我们致力于与医生密切合作，找出中风护理中的关键差距，并提供创新解决方案，为患者带来有意义的益处。Zoom 6F插入式导管的推出展示了我们临床合作的核心宗旨，将一线医生的观点置于我们研发过程的中心。”。。

The Zoom 6F Insert Catheter portfolio consists of the Zoom SIM, Zoom VRT, and Zoom VTK technologies – all unique in their shape, construction and length with the goal of helping physicians achieve faster and more reliable intracranial access in a wide range of patient anatomies.

Zoom 6F插入式导管组合由Zoom SIM、Zoom VRT和Zoom VTK技术组成，它们在形状、结构和长度上都是独一无二的，目的是帮助医生在各种患者解剖结构中实现更快、更可靠的颅内通路。

In the first case performed by Dr. Tomalty, the Zoom SIM Insert Catheter was used to quickly select the target vessel and provide .088” intracranial access from the femoral artery with Zoom 88 in a patient with a challenging anatomy and distal left M2 occlusion. The Zoom SIM provided added stability to navigate Zoom 88 far into the brain and access the clot more quickly.

在Tomalty博士进行的第一例病例中，Zoom SIM插入导管用于快速选择目标血管，并在具有挑战性解剖结构和远端左侧M2闭塞的患者中使用Zoom 88从股动脉提供0.088“颅内通路。Zoom SIM卡提供了额外的稳定性，可以将Zoom 88导航到大脑深处，并更快地接近血块。

Dr. Tomalty then used both Zoom 71 and Zoom 35 to aspirate and remove the clot in only 10 minutes from puncture to reperfusion, resulting in a complete TICI 3 revascularization..

随后，Tomalty 博士使用 Zoom 71 和 Zoom 35 吸出并清除血凝块，从穿刺到再灌注仅用了 10 分钟，实现了完全的 TICI 3 级血管再通。

“In my experience, navigating the aortic arch can pose a significant challenge in patients with more tortuous anatomy. Due to the unique design and capabilities of the Zoom 6F Insert Catheters, I believe the use of these technologies will help mitigate this challenge and take minutes off my stroke thrombectomy times, allowing me to get the clot out faster,” Tomalty said..

托马尔蒂说：“根据我的经验，主动脉弓的导航对于解剖结构更加曲折的患者来说是一个巨大的挑战。由于Zoom 6F插入式导管的独特设计和功能，我相信这些技术的使用将有助于缓解这一挑战，并减少中风血栓切除时间，使我能够更快地取出血栓。”。。

Clinical evidence shows that the Zoom Stroke Solution can help physicians achieve better reperfusion and faster cases with fewer devices in stroke procedures1,2. Imperative Care is the first company to offer a comprehensive portfolio designed for physicians to rapidly achieve intracranial access from the puncture site to quickly reach the target location and diagnose the clot location, allowing the physician to deliver the ideal aspiration thrombectomy catheter to completely remove the clot.

临床证据表明，Zoom Stroke解决方案可以帮助医生在中风过程中使用更少的设备实现更好的再灌注和更快的病例1,2。紧急护理是第一家为医生提供全面投资组合的公司，旨在快速实现穿刺部位的颅内通路，以快速到达目标位置并诊断凝块位置，从而使医生能够提供理想的抽吸血栓切除导管以完全清除凝块。

This allows the physician to achieve fast and effective reperfusion for the best possible outcome for the patient..

这使医生能够实现快速有效的再灌注，为患者提供最佳的结果。。

About the Zoom Stroke Solution

关于缩放笔划解决方案

The Zoom Stroke Solution is the complete stroke system from access through reperfusion for fast and effective clot removal in patients presenting with acute ischemic stroke. The system includes a comprehensive access portfolio consisting of the Zoom 6F Insert Catheters, Zoom 88 and Zoom 88 Support Large Distal Platform, Zoom RDL Radial Access Platform, four vessel-matched Zoom Aspiration Catheters, Zoom Pump, Zoom POD and accessories.

Zoom Stroke解决方案是从进入到再灌注的完整中风系统，可用于急性缺血性中风患者的快速有效血栓清除。该系统包括一个全面的接入组合，包括Zoom 6F插入导管，Zoom 88和Zoom 88支持大型远端平台，Zoom RDL径向接入平台，四血管匹配的Zoom抽吸导管，Zoom泵，Zoom POD和配件。

All Zoom Aspiration Catheters are designed with the unique TRX™ Tip, which provides 15% greater clot engagement area at the tip of the catheter3 and are designed to enable smooth tracking through challenging vasculature. For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: http://bit.ly/2Vx0Qcf.

所有Zoom抽吸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3，并设计用于通过具有挑战性的脉管系统进行平滑追踪。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：http://bit.ly/2Vx0Qcf.

About Imperative Care, Inc.

关于Imperative Care

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.

Imperative Care,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。