ALAMEDA, Calif., April 23, 2024 — Penumbra, Inc. (NYSE: PEN), the world’s largest thrombectomy company, announced the U.S. Food and Drug Administration (FDA) clearance and launch of Lightning Flash™ 2.0, the next generation computer assisted vacuum thrombectomy (CAVT) system to remove venous thrombus and treat pulmonary emboli (PE).

加利福尼亚州阿拉米达，2024年4月23日讯-世界最大的血栓切除术公司Penumbra，Inc.（纽约证券交易所代码：PEN）宣布美国食品和药物管理局（FDA）批准并推出Lightning Flash™2.0，这是下一代计算机辅助真空血栓切除术（CAVT）系统，用于去除静脉血栓和治疗肺栓塞（PE）。

Lightning Flash 2.0 features advanced Lightning Flash algorithms, designed for increased speed and sensitivity to thrombus and blood flow. These new advancements combined with Penumbra’s novel catheter technology allow physicians to better navigate the body’s complex anatomy and deliver high power for clot removal with possible minimal blood loss..

闪电2.0采用先进的闪电算法，旨在提高速度和对血栓和血流的敏感性。这些新的进步与Penumbra的新型导管技术相结合，使医生能够更好地导航身体复杂的解剖结构，并提供高功率的凝块清除能力，同时尽可能减少失血量。。

“Based on what we’ve seen in the initial launch, Lightning Flash 2.0 has significantly improved procedure time by shortening the aspiration time. It has also shown reductions in blood removed during aspiration. These advantages can improve patient safety, provide better outcomes for the patients, and streamline efficiency for physicians treating the patients,” said James F.

James F。

Benenati, M.D., FSIR, chief medical officer at Penumbra. “As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 will provide physicians with the confidence that CAVT is a valuable frontline option.”.

Penumbra首席医疗官、医学博士Benenati，FSIR。“随着血栓切除术的应用越来越广泛，闪电2.0将为医生提供信心，认为CAVT是一种有价值的前线选择。”。

With streamlined audio-visual feedback, Lightning Flash 2.0 enables physicians to have a better understanding of what is occurring at the tip of the catheter during a procedure. This enhanced feedback loop results in a more intuitive thrombus removal experience for the physician.

通过简化的视听反馈，Lightning Flash 2.0使医生能够更好地了解手术过程中导管尖端发生的情况。这种增强的反馈回路为医生带来了更直观的血栓清除体验。

“Lightning Flash 2.0 now combines an optimally sized catheter with the latest algorithm technology designed to more efficiently remove blood clots while maintaining a high level of safety,” said Adam Elsesser, president and chief executive officer of Penumbra. “Our ongoing innovation around CAVT underscores our commitment to advancing patient care so that more patients suffering from these complicated conditions can benefit from this advanced therapy.”.

Penumbra总裁兼首席执行官亚当·埃尔塞瑟（AdamElsesser）表示：“闪电2.0现在将最佳尺寸的导管与最新算法技术相结合，旨在更有效地去除血块，同时保持高水平的安全性。”。“我们正在围绕CAVT进行的创新强调了我们对推进患者护理的承诺，以便更多患有这些复杂疾病的患者可以从这种先进疗法中受益。”。

Lightning Flash 2.0 is part of Penumbra’s Indigo® System with Lightning® portfolio. The company’s Lightning products are the only computer assisted mechanical thrombectomy systems currently available in the U.S. and early clinical data has demonstrated improvement in patient clinical outcomes and quality of lifei..

Lightning Flash 2.0是Penumbra Indigo®系统和Lightning®产品组合的一部分。该公司的Lightning产品是目前美国唯一可用的计算机辅助机械血栓切除系统，早期临床数据表明患者临床结果和生活质量有所改善。。

About Penumbra

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Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions. Penumbra supports healthcare providers, hospitals and clinics in more than 100 countries.

Penumbra，Inc.，总部位于加利福尼亚州阿拉米达，是一家专注于创新疗法的全球医疗保健公司。Penumbra设计、开发、制造和销售新颖的产品，拥有广泛的产品组合，可应对具有挑战性的医疗条件。Penumbra支持100多个国家的医疗保健提供者、医院和诊所。