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ALAMEDA, Calif., Oct. 14, 2024 — Penumbra, Inc. (NYSE: PEN), the world’s leading thrombectomy company, announced the completion of enrollment in its THUNDER clinical study for patients with acute ischemic stroke. THUNDER is evaluating the safety and efficacy of the company’s latest computer assisted vacuum thrombectomy (CAVT™) technology, Penumbra System™ with Thunderbolt™ Aspiration Tubing, for the removal of blood clots in the brain..
加利福尼亚州阿拉米达,2024年10月14日消息,世界领先的血栓切除术公司Penumbra,Inc.(纽约证券交易所代码:PEN)宣布完成其针对急性缺血性卒中患者的THUNDER临床研究。THUNDER正在评估该公司最新的计算机辅助真空血栓切除术(CAVT™)技术的安全性和有效性,该技术是带有Thunderbolt™抽吸管的Penumbra System™,用于去除大脑中的血栓。。
“This critical milestone brings us another step closer to providing physicians with the latest technology for stroke management,” said Adam Elsesser, president and chief executive officer of Penumbra. “The THUNDER study will provide the data set needed to evaluate Penumbra’s Thunderbolt technology and I am optimistic that we are at the dawn of a new era in stroke treatment.”.
Penumbra总裁兼首席执行官亚当·埃尔塞瑟(AdamElsesser)表示:“这一关键里程碑使我们离为医生提供最新的中风管理技术又近了一步。”。“THUNDER研究将提供评估Penumbra Thunderbolt技术所需的数据集,我乐观地认为,我们正处于中风治疗新时代的黎明。”。
Penumbra System with Thunderbolt Aspiration Tubing uses an advanced CAVT software algorithm to generate proprietary modulated aspiration, reducing friction between the clot and reperfusion catheter and facilitating a more rapid and complete removal of blood clots in the brain. Thunderbolt Aspiration Tubing has been designed for use with Penumbra ENGINE™ and RED™ reperfusion catheters..
带有霹雳抽吸管的半影系统使用先进的CAVT软件算法来产生专有的调制抽吸,减少凝块和再灌注导管之间的摩擦,并促进更快速和完全去除大脑中的血块。霹雳抽吸管设计用于Penumbra ENGINE™和RED™再灌注导管。。
The THUNDER study (NCT05437055) is a multi-center, single-arm study evaluating patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy. The primary efficacy endpoint includes revascularization of the occluded target vessel at immediate post-procedure..
THUNDER研究(NCT05437055)是一项多中心单臂研究,评估继发于颅内大血管闭塞(LVO)的急性缺血性卒中患者,这些患者有资格进行机械血栓切除术。主要疗效终点包括术后即刻闭塞靶血管的血运重建。。
About PenumbraPenumbra Inc., the world’s leading thrombectomy company, is focused on developing the most innovative technologies for challenging medical conditions such as ischemic stroke, venous thromboembolism such as pulmonary embolism, and acute limb ischemia. Its broad portfolio, which includes computer assisted vacuum thrombectomy (CAVT), centers on removing blood clots from head-to-toe with speed, safety and simplicity.
关于PenumbraPenumbra Inc.,世界领先的血栓切除术公司,专注于开发最具创新性的技术,以应对缺血性中风,静脉血栓栓塞(如肺栓塞)和急性肢体缺血等具有挑战性的医疗条件。其广泛的产品组合,包括计算机辅助真空血栓切除术(CAVT),以快速,安全和简单的方式从头到脚清除血栓为中心。
By pioneering these innovations, Penumbra supports healthcare providers, hospitals and clinics in more than 100 countries, working to improve patient outcomes and quality of life. For more information, visit www.penumbrainc.com and connect on Instagram, LinkedIn and X..
通过开创这些创新,Penumbra为100多个国家的医疗保健提供者、医院和诊所提供支持,致力于改善患者的预后和生活质量。有关更多信息,请访问www.penumbrainc.com,并在Instagram、LinkedIn和X上进行连接。。
Important Safety InformationAdditional information about Penumbra’s products can be located on Penumbra’s website at https://www.penumbrainc.com/providers. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use.
重要安全信息有关Penumbra产品的其他信息,请访问Penumbra的网站https://www.penumbrainc.com/providers.使用前,请参阅完整的产品适应症、禁忌症、警告、注意事项、潜在不良事件和详细的使用说明。
Risk information can be found at http://www.peninc.info/risk..
风险信息可在http://www.peninc.info/risk..
Forward-Looking StatementsExcept for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements.
前瞻性声明除历史信息外,本新闻稿中的某些声明具有前瞻性,并受到有关我们的风险、不确定性和假设的影响。我们的业务和运营受到各种风险和不确定性的影响,因此,实际结果可能与任何前瞻性声明所预测的结果存在重大差异。
Factors that could cause actual results to differ from those projected include, but are not limited to: failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory or other assets; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; potential adverse regulatory actions; and the potential impact of any acquisitions, mergers, dispositions, joint ventures or investments we may make.
;未能有效引进和推广新产品;延迟产品介绍;重大竞争;无法进一步渗透我们目前的客户群,扩大我们的用户群,增加客户使用我们产品的频率;无法实现或维持令人满意的定价和利润率;制造困难;存货或其他资产的永久性减记或注销;产品缺陷或故障;临床试验的不利结果;随着我们的成长,无法维持我们的文化;外币汇率波动;潜在的不利监管行动;以及我们可能进行的任何收购、合并、处置、合资企业或投资的潜在影响。
These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 22, 2024. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business.
这些风险和不确定性以及其他风险和不确定性将在我们向美国证券交易委员会(SEC)提交的文件中进行更详细的讨论,包括我们于2024年2月22日向SEC提交的截至2023年12月31日的10-K表年度报告。可能存在我们目前不知道或我们目前认为不重要的额外风险,这可能会对我们的业务产生不利影响。
Any forward-looking statements are based on our current expe.
任何前瞻性声明都是基于我们目前的经验。
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Jennifer Heth
珍妮弗·赫斯
Parinaz Farzin
Parinaz Farzin
Penumbra, Inc.
半影公司。
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SOURCE Penumbra, Inc.
SOURCE Penumbra公司。
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