New late breaking data demonstrate Indigo Aspiration System with Lightning, for pulmonary embolism improved patient outcomes.- Penumbra Inc.

The results show Penumbra’s computer assisted vacuum thrombectomy (CAVT) is safe and effective at reducing right heart strain. It also improved clinical outcomes, including heart rate and respiratory rate, and functional outcomes, including dyspnea, walking distance and New York Heart Association (NYHA) classification, when used to treat acute high and intermediate risk pulmonary embolism (PE). The data were presented at this week’the Vascular Interventional Advances (VIVA) 2023 Conference.

The latest STRIKE-PE data looking at the first 150 patients show that not only is Penumbra’s Indigo System safe and effective for removing thrombus, but also confirm that the removal of the clot can have a significant, positive physiologic impact on patients,” said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. “The latest STRIKE-PE data add to the growing body of evidence that demonstrates the significant benefits of CAVT, which is redefining the way physicians treat significant symptomatic pulmonary emboli.”

Penumbra’s CAVT is designed to allow physicians to remove large blood clots in the body safely, simply and with speed. The interim results of the prospective, muti-center study, which evaluated Penumbra’s Lightning technology in 150 of 600 anticipated patients to be enrolled, include: Safety & Performance : i. Low 48hr major adverse event rate of 2.7%. ii. Low 48hr major bleeding rate of 2.7%. iii. Significant reduction of right ventricle/left ventricle ratio by 25.7%. Functional Measures : i. Significantly improved patient reported shortness of breath (dyspnea) by discharge with increasing improvement by 90-days. ii. Functional ability, measured by 6-minute walk distance, significantly increased by 120 meters from discharge to 90-days. iii. Patients returned to pre-PE state with no significant difference in NYHA classification from before the event to 90-days.

Additional STRIKE-PE data were previously presented at the recent TCT Annual Scientific Meeting, showing improved quality-of-life outcomes , including improved mobility and ability to provide self-care and a decrease in pain/discomfort from discharge to 90-day follow-up.

“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.”

Penumbra is also conducting STORM-PE , a first-of-its kind randomized controlled trial comparing CAVT using Penumbra’s Lightning Flash with anticoagulation versus anticoagulation alone, with the goal of showing the clinical benefits to patients who receive CAVT.