Penumbra Expands STRIKE-PE Study to 1500 Patients

Penumbra is expanding its STRIKE-PE Study, increasing patient enrollment from 600 to up to 1,500 patients. This expansion will extend the trial beyond the United States and Europe, making it one of the largest and most comprehensive pulmonary embolism (PE) trials with long-term functional and quality of life data.

With a more diverse and extensive patient population, researchers will be able to conduct more nuanced analyses, identifying variations in treatment outcomes across different demographics, risk stratification and clinical presentations. This can lead to a deeper understanding of PE and more personalized approaches to treatment. Additionally, the inclusion of international sites will provide insights into how different healthcare systems and practices impact patient outcomes, further enriching the study’s findings.

Increasing patient enrollment enriches our dataset, enabling detailed subgroup analyses, particularly for higher-risk patient populations,” said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. “The additional data will allow us to gather insights from a broader, more diverse population, which will ultimately help improve the care of PE patients around the world.”

STRIKE-PE is a prospective, international, multicenter study evaluating real-world safety, performance, and long-term quality-of-life outcomes of computer-assisted vacuum thrombectomy (CAVT^™) with Penumbra’s Indigo^® Aspiration System for the treatment of PE.

Learn more about the STRIKE-PE Study: https://www.penumbrainc.com/strike-pe-study/

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.