Core Insights - The STORM-PE randomized controlled trial demonstrated that computer assisted vacuum thrombectomy (CAVT) combined with anticoagulation significantly improves clinical outcomes in patients with acute intermediate-high risk pulmonary embolism (PE) compared to anticoagulation alone [1][6][15] Study Overview - STORM-PE is a pivotal, multi-center randomized controlled trial involving 100 patients across 22 international sites, comparing CAVT with anticoagulation against anticoagulation alone for treating acute intermediate-high risk PE [2][8] - The trial's primary efficacy endpoint was the reduction in right ventricular to left ventricular (RV/LV) ratio at 48 hours, assessed by an independent core laboratory [8] Key Findings - Patients receiving CAVT plus anticoagulation showed a 2.7 times greater reduction in thrombus burden (42.1% vs. 15.6% relative reduction; P < 0.001) [7] - Significant early physiological recovery was observed, with lower heart rates (80.0 bpm vs. 86.4 bpm; P = 0.022) and reduced supplemental oxygen requirements (0.5 L/min vs. 1.4 L/min; P = 0.027) [7] - CAVT patients had a 2.2 times greater likelihood of recovering functional status by discharge (P = 0.032) and walked significantly longer distances in a 90-day six-minute walk test (472m vs. 376m; P = 0.019) [7] Safety Profile - The safety profile of CAVT was comparable to anticoagulation alone, with no device-related mortality and no significant difference in symptomatic PE recurrence [7][4] Implications for Patient Care - The results of the STORM-PE trial highlight the importance of early intervention in patients with intermediate-high risk PE and suggest that CAVT could be a superior therapeutic option, potentially influencing future treatment guidelines [3][4]

Core Insights - Penumbra, Inc. has completed enrollment in the STORM-PE clinical trial, which is a pioneering study comparing computer-assisted vacuum thrombectomy (CAVT™) using Penumbra's Lightning Flash™ with anticoagulation versus anticoagulation alone for treating acute intermediate-high risk pulmonary embolism [1][2] - The trial enrolled 100 patients and aims to provide high-quality evidence on the effectiveness of CAVT in improving right heart function and clinical outcomes in patients with pulmonary embolism [1][2][4] - Pulmonary embolism is a significant health concern, with an estimated 900,000 symptomatic cases occurring annually in the U.S., and a mortality rate of 10-30% within one month of diagnosis [3] Company Overview - Penumbra, Inc. is recognized as the world's leading thrombectomy company, focusing on innovative technologies for medical conditions such as ischemic stroke and venous thromboembolism [6] - The company's Lightning Flash portfolio features advanced mechanical thrombectomy systems designed to remove blood clots efficiently, utilizing dual clot detection algorithms and a specialized catheter design [4][6] - Penumbra operates in over 100 countries, aiming to enhance patient outcomes and quality of life through its innovative medical solutions [6]