EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced successful early clinical use of the company’s Pounce™ LP (Low Profile) Thrombectomy System. The Pounce LP Thrombectomy System, which received U.S.

明尼苏达州伊甸园大草原（商业新闻短讯）--医疗器械和体外诊断技术的领先供应商Surmodics，Inc.（纳斯达克：SRDX）今天宣布，该公司的突袭技术已成功早期临床应用™ LP（低轮廓）血栓切除系统。Pounce LP血栓切除系统，该系统接受了美国。

Food and Drug Administration (FDA) clearance in June 2023, is currently in limited market evaluation (LME), with full commercial launch planned following completion of the LME..

食品和药物管理局（FDA）于2023年6月获得批准，目前正在进行有限市场评估（LME），计划在LME完成后全面商业启动。。

Surmodics’ Pounce Thrombectomy devices are intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. The new Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm to 4 mm in diameter, sizes typical of vessels found below the knee.

Surmodics的突袭血栓切除装置旨在非手术切除外周动脉脉管系统中的血栓和栓子。新的Pounce LP血栓切除系统适用于直径2毫米至4毫米的血管，这些血管的尺寸是膝下血管的典型尺寸。

The Pounce LP System complements the original Pounce Thrombectomy System, introduced in 2021, which is indicated for use in vessels 3.5 mm to 6 mm in diameter..

Pounce LP系统是对2021年推出的原始Pounce血栓切除系统的补充，该系统适用于直径3.5 mm至6 mm的血管。。

Dr. Lucas Ferrer Cardona,* a vascular surgeon with the Dell Seton Medical Center at the University of Texas Hospital in Austin, was the first physician to use the Pounce LP System.

卢卡斯·费雷尔·卡多纳（LucasFerrerCardona）博士是奥斯汀德克萨斯大学医院戴尔·塞顿医学中心（Dell Seton Medical Center）的血管外科医生，是第一位使用庞贝LP系统的医生。

“In our first use of the device, the Pounce LP Thrombectomy System performed exceptionally well in helping our team restore blood flow to the foot for a limb-threatened patient,” he said. “Using the device, we promptly removed acute and subacute thrombus from the mid-peroneal artery below the knee with no adjunctive use of thrombolytics and no embolization.

他说：“在我们首次使用该设备时，Pounce LP血栓切除系统在帮助我们的团队恢复肢体受威胁患者足部血流方面表现异常出色。”。“使用该装置，我们迅速清除了膝下腓中动脉的急性和亚急性血栓，无需辅助使用溶栓剂，也无需栓塞。

Thrombi or emboli in below-the-knee vessels have traditionally been very challenging to remove. I believe this device holds great promise in filling a major gap in our treatment algorithm.”.

膝下血管中的血栓或栓子传统上很难清除。我相信这种设备在填补我们治疗算法的主要空白方面具有很大的前景。”。

Dr. Elizabeth Genovese, a vascular surgeon at the Hospital of the University of Pennsylvania who has experience using the original Pounce System, is among several other satisfied early users of the Pounce LP System. She recently deployed the Pounce LP device to revascularize a patient with arterial occlusions in both the anterior tibial and peroneal arteries..

宾夕法尼亚大学医院的血管外科医生伊丽莎白·吉诺维斯博士（ElizabethGenovese）拥有使用原始Pounce系统的经验，也是Pounce LP系统的其他几个满意的早期用户之一。她最近部署了Pounce LP装置，对胫前动脉和腓动脉闭塞的患者进行血运重建。。

“The Pounce LP System allowed me to treat chronic thrombus in these vessels with the effectiveness I’d expect from open surgical Fogarty embolectomy while maintaining the advantages of an endovascular approach for treating underlying and distal disease,” she said. “We were able to achieve an optimal outcome in a very complex lesion, and this type of result would not have been possible without this device.”.

她说：“POUMCE LP系统使我能够以开放手术Fogarty取栓术所期望的效果治疗这些血管中的慢性血栓，同时保持血管内方法治疗潜在和远端疾病的优势。”。“我们能够在非常复杂的病变中获得最佳结果，如果没有这种设备，这种结果是不可能的。”。

“We’re very pleased with the successful early clinical use of the Pounce LP Thrombectomy System, which will extend the range of treatment for our Pounce platform to include removal of organized thrombotic or embolic clots from the iliac arteries in the pelvis down to tibial vessels below the knee,” said Gary Maharaj, President and Chief Executive Officer of Surmodics.

Surmodics总裁兼首席执行官加里·马哈拉吉（GaryMaharaj）表示：“我们对Pounce LP血栓切除系统的成功早期临床应用感到非常高兴，该系统将扩大我们Pounce平台的治疗范围，包括从骨盆髂动脉到膝下胫骨血管清除有组织的血栓或栓塞凝块。”。

“Downstream embolization of chronic material into below-the-knee arteries during an endovascular procedure can be an interventionist’s nightmare, sometimes requiring surgical rescue. The Pounce LP System’s ability to capture and remove these unexpected emboli adds yet more value to this device for BTK revascularization.”.

“在血管内手术过程中，将慢性物质下游栓塞到膝下动脉可能是干预主义者的噩梦，有时需要手术抢救。Pounce LP系统捕获和移除这些意外栓塞的能力为BTK血运重建增加了更多价值。”。

About the Pounce Thrombectomy Platform

关于突袭血栓切除平台

The Pounce System is the first mechanical thrombectomy device designed to remove acute-to-chronic thrombi and emboli in occluded peripheral arteries without the need for capital equipment or aspiration and minimizing the use of thrombolytics. Described as a “grab-and-go” solution, the Pounce System is both readily deployable and simple to use.

Pounce系统是第一个机械血栓切除装置，旨在去除闭塞的外周动脉中的急性至慢性血栓和栓子，而无需资本设备或抽吸，并最大程度地减少溶栓剂的使用。该突袭系统被描述为“抓取即走”的解决方案，既易于部署，又易于使用。

The System is composed of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel.

该系统由三个部件组成：输送导管，篮状线和漏斗导管。篮状钢丝被输送到血栓位置的远端，部署两个镍钛合金自膨胀篮。篮子捕获凝块并缩回镍钛诺收集漏斗。

With the clot entrained, the System is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body. The Pounce Thrombectomy platform includes two different-sized devices: the original Pounce™ Thrombectomy System, indicated for use in peripheral arterial vessels 3.5 mm to 6 mm in diameter, and the Pounce LP (Low Profile) Thrombectomy System, indicated for use in peripheral arterial vessels 2 mm to 4 mm in diameter..

随着凝块的夹带，系统被撤回到最小7 Fr的引导鞘中，通过该鞘将凝块从体内移除。突袭血栓切除平台包括两个不同大小的设备：原始突袭™ 血栓切除系统，适用于直径3.5毫米至6毫米的外周动脉血管，以及POUMCE LP（低轮廓）血栓切除系统，适用于直径2毫米至4毫米的外周动脉血管。。

In a retrospective study 3 of 44 consecutive patients treated for lower extremity limb ischemia with suspected thrombus using the original Pounce System (acute, subacute, and chronic clot), investigators achieved 83% success in effectively removing thrombus from the arterial segments in which the device was used.

在一项回顾性研究中，使用原始突袭系统（急性，亚急性和慢性凝块）对44例疑似血栓的下肢缺血患者进行了回顾性研究，研究人员在有效清除动脉段血栓方面取得了83%的成功。该设备被使用。

Adjunctive thrombolysis was used to resolve thrombus at a Pounce System treatment site in just 5.6% (2 of 44) cases..

辅助溶栓治疗仅在5.6%（44例中的2例）的突袭系统治疗部位用于解决血栓。。

About Surmodics, Inc.

关于Surmodics，Inc。

Surmodics is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements.

Surmodics是血管内医疗设备性能涂层技术以及用于体外诊断免疫测定测试和微阵列的化学和生物成分的领先供应商。Surmodics还开发和商业化高度分化的血管介入医疗设备，旨在满足未满足的临床需求，并根据最苛刻的要求进行设计。

This key growth strategy leverages the combination of the Company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development, and manufacturing capabilities. The Company’s mission is to improve the detection and treatment of disease.

这一关键的增长战略利用了该公司在专有表面改性和药物输送涂层技术方面的专业知识，以及其设备设计、开发和制造能力。该公司的使命是改进疾病的检测和治疗。

Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com. The content of Surmodics’ website is not part of this press release or part of any filings that the company makes with the Securities and Exchange Commission..

Surmodics的总部位于明尼苏达州的伊甸草原。有关更多信息，请访问www.surmodics.com。surmodics网站的内容不属于本新闻稿或公司向证券交易委员会提交的任何文件的一部分。。

Safe Harbor for Forward-Looking Statements

前瞻性声明的安全港

This press release contains forward-looking statements. Statements that are not historical or current facts, including statements regarding what the Pounce LP Thrombectomy System is designed to address, the planned full commercial launch of the product, the promise of the product, and Surmodics’ strategy, are forward-looking statements.

本新闻稿包含前瞻性声明。非历史或当前事实的陈述，包括关于庞贝LP血栓切除系统旨在解决的问题，产品计划的全面商业发布，产品的承诺以及Surmodics的战略的陈述，都是前瞻性的陈述。

Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the results of the limited market evaluation of the Pounce LP Thrombectomy System, adoption of the product, and the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2023, and updated in our subsequent reports filed with the SEC.

前瞻性陈述涉及固有风险和不确定性，重要因素可能导致实际结果与预期结果存在重大差异，包括庞贝LP血栓切除系统有限市场评估的结果、产品的采用以及第一部分“风险因素”中确定的因素，截至2023年9月30日止财政年度的10-K表年度报告第1A项，并在随后提交给SEC的报告中进行了更新。

These reports are available in the Investors section of our website at https://surmodics.gcs-web.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events..

这些报告可在我们网站的投资者部分获得https://surmodics.gcs-web.com在美国证券交易委员会网站www.SEC.gov上。前瞻性声明仅在发布之日起生效，我们没有义务根据新信息或未来事件对其进行更新。。

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在businesswire.com上查看源版本：https://www.businesswire.com/news/home/20230614697020/en/

* Consultant for Surmodics

*Surmodics顾问

Gray BH, Wheibe E, Dicks AB, Low ML, Tingen JS. Pounce Thrombectomy System to Treat Acute and Chronic Peripheral Arterial Occlusions. Ann Vasc Surg. 2023;96:104-114.

格雷BH，惠比E，迪克AB，低ML，廷根JS。Pounce血栓切除系统治疗急性和慢性外周动脉闭塞。Ann Vasc Surg。2023年；96:104-114。