Latest STRIKE-PE Data Published in JVIR Showing that Penumbra’s Computer Assisted Vacuum Thrombectomy Technology For Pulmonary Embolism Improved Patient Outcomes

Real-world data from the STRIKE-PE Study – showing that computer assisted vacuum thrombectomy (CAVT^™) for the treatment of pulmonary embolism (PE) is safe and effective at reducing right heart strain, as well as improving quality of life and functional outcomes – has been published in the Journal of Vascular and Interventional Radiology¹. The article is slated to be included as a Featured Article in the journal’s upcoming August 2024 issue.

In the U.S., an estimated 900,000 cases of symptomatic PE occur annually². Incomplete physical recovery after PE has been documented as a common outcome as patients often report decreased quality of life and persistent shortness of breath. Pulmonary embolism can be life-threatening with 10-30 percent of individuals dying within one month of diagnosis².

“The real-world data from STRIKE-PE allow us, for the first time, to continuously evaluate the impact of intermediate and high-risk PE treated with CAVT,” said John Moriarty, M.D., principal investigator of the STRIKE-PE study and interventional radiologist at University of California, Los Angeles. “The latest results continue to show improved functional outcomes and quality of life, suggesting that CAVT should be considered as a valuable frontline treatment option.”

The interim results of the prospective, multi-center study, which evaluated Penumbra’s Indigo^® Aspiration System with Lightning^® technology in 150 of 600 anticipated patients to be enrolled, include:

Safety & Performance:

• Low 48hr major adverse event rate of 2.7%
• Low 48hr major bleeding rate of 2.7%
• Significant reduction of right ventricle/left ventricle ratio by 25.7%

Functional Measures:

• Significantly improved patient reported shortness of breath (dyspnea) by discharge with increasing improvement by 90-days
• Patients returned to pre-PE state with no significant difference in NYHA classification from before the event to 90-days
• Significant improvements were reported for all EQ-5D-5L dimensions, EQ-5D-5L index value, EQ VAS, and overall PEmb-QoL score.

More recently, the STRIKE-PE study expanded to 1500 patients.

Penumbra’s CAVT technology includes advanced clot detection algorithms, designed for increased speed during the procedure and increased sensitivity to thrombus and blood flow. These latest advancements combined with Penumbra’s catheter technology allow physicians to better navigate the body’s complex anatomy and deliver high vacuum power for clot removal.

Important Safety Information

Additional information about Penumbra’s products can be located on Penumbra’s website at https://www.penumbrainc.com/products/peripheral-thrombectomy-indigo-system/. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. Risk information can be found at peninc.info/risk.

The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.

1. Moriarty JM, Dohad SY, Schiro BJ, et al. Clinical, functional, and quality of life outcomes after computer assisted vacuum thrombectomy for pulmonary embolism: interim analysis of the STRIKE-PE study. J Vasc Interv Rad. 2024, May 8. DOI:https://doi.org/10.1016/j.jvir.2024.04.028
2.American Lung Association. Learn about Pulmonary Embolism. https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism. Accessed on Oct. 26, 2023.