CIRSE 2026: New STRIKE-PE Analysis Shows Sustained Improvements in Functional Outcomes and Quality of Life One Year After CAVT Treatment

A new analysis from the STRIKE-PE study demonstrates significant and sustained improvements in functional status and quality of life one year after treatment with computer assisted vacuum thrombectomy (CAVT^®) for acute pulmonary embolism (PE). The data was presented by principal investigator John Moriarty, MD, interventional radiologist at the University of California, Los Angeles (UCLA) at CIRSE 2026 on September 7th.

“For patients who survive pulmonary embolism, recovery extends far beyond the acute event,” said Dr. Moriarty. “The STRIKE-PE one-year data shows that CAVT pairs strong clinical outcomes with meaningful improvements in function and quality of life, with many patients returning to a physical status comparable to what they experienced before their PE. These findings underscore the importance of measuring outcomes that matter most to patients as they move through recovery.”

While pulmonary embolism (PE) is often viewed through the lens of acute mortality and right ventricular dysfunction, many survivors face persistent symptoms long after the initial event. Shortness of breath, reduced exercise capacity, and diminished quality of life can impact patients for months or years following PE, making long-term recovery an increasingly important measure of treatment success.

The new analysis extends the STRIKE-PE findings beyond the acute treatment period, offering insight into how patients recover over time. Results showed sustained improvements across measures of functional status, symptom burden, exercise capacity, and quality of life through one year.

The analysis included 584 patients treated with the Lightning Flash^® 16F catheter system. One-year follow-up data were available for 208 of those patients.

Key findings include:

Primary Performance Endpoint

• Mean RV/LV ratio decreased 27.2%, from 1.36 at baseline to 0.96 at 48 hours (P < .001)

Primary Safety Endpoint

• Composite MAE rate within 48 hours was 1.5%

Device Time

• Median thrombectomy time was 25 minutes

NYHA Functional Class

• By 90 days after CAVT, NYHA functional class distribution had returned to levels comparable to patients’ pre-PE functional status and was sustained through 1-year (P = .028)

Six-Minute Walk Test (6MWT)

• Mean six-minute walk distance increased from 347.4 meters at 90 days to 383.7 meters at 1- year after CAVT (P < .001)

Borg Dyspnea Scale

• Median dyspnea at rest score improved from 5.0 at baseline to 0.0 at 90 days and was sustained 1-year after CAVT (P < .001)
• Median dyspnea after 6-minute walk test was 0.5 at 1-year after CAVT, demonstrating sustaining improvement (P = 0.095).

Quality of Life Measures

Investigators observed significant improvements across validated quality-of-life assessments.

• Mean EQ Visual Analog Scale (EQ VAS) improved from 53.2 at baseline to 79.0 at 1-year after CAVT (P < .001)
• At 1-year after CAVT, EQ-5D-5L index value improved to near the US population norm (0.799 vs. 0.815), with improvement from baseline exceeding the reported MCID range (P = .11)
• Mean Total Pulmonary Embolism Quality of Life Questionnaire Score (PEmb-QoL) improved from 42.5 at baseline to 14.1 at 1-year after CAVT (P < .001), exceeding the reported MCID by approximately twofold

“As PE care continues to evolve, it is important to evaluate outcomes across the entire patient journey,” said James F. Benenati, MD, chief medical officer at Penumbra. “These data build on the clinical outcomes observed in STRIKE-PE and provide evidence that patients experienced sustained improvements in functional status, exercise capacity, and quality of life through one year after treatment with CAVT.”

As the field increasingly focuses on patient-centered outcomes, these findings contribute important evidence that recovery after PE should be measured not only by what happens in the first 48 hours, but also by how patients are able to live, function, and thrive in the year that follows.

Learn more about STRIKE-PE.

Important Safety Information

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

Copyright ©2026 Penumbra, Inc. All rights reserved. CAVT and Lightning Flash are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries.