Penumbra Presents Interim Data From STRIKE-PE Study at VIVA Showing the Indigo Aspiration System Led to Positive Outcomes for Pulmonary Embolism Patients
11-1-23 (by: Scott Gleason) Penumbra has unveiled new data from its STRIKE-PE study, demonstrating the efficacy of Penumbra’s computer-assisted vacuum thrombectomy (CAVT) in reducing right heart strain. The study, presented at the recent Vascular Interventional Advances (VIVA) 2023 Conference, also highlighted improved clinical and functional outcomes when treating acute high and intermediate risk pulmonary embolism (PE) with Penumbra’s Indigo® Aspiration System with Lightning™.
Penumbra’s CAVT system is designed to facilitate the safe, efficient, and rapid removal of large blood clots within the body. The interim results from the prospective, multi-center STRIKE-PE study, which evaluated the Lightning technology in 150 patients (out of an anticipated 600), showed a 48 hour adverse event rate of 2.7%, a 48 hour major bleeding rate of 2.7%, and a reduction in right ventricle/left ventricle ratio of 25.7%. Right ventricle/left ventricle ratio is used to diagnose pulmonary embolisms. A normal ratio is 0.6 and a ratio greater than 1.0 is associated with pulmonary embolism.
The study also showed a substantial improvement in patient-reported shortness of breath (dyspnea) by discharge, with further enhancement at the 90-day mark and a significant improvement in functional ability, as indicated by a 120-meter increase in the 6-minute walk distance from discharge to 90 days. Additionally, patients returned to their pre-PE state, with no significant difference in New York Heart Association (NYHA) classification from before the event to 90 days post treatment.
Dr. John Moriarty, Principal Investigator of the STRIKE-PE study and an interventional radiologist at the University of California, Los Angeles, emphasized the importance of these results, suggesting that CAVT should be considered a valuable frontline treatment option.
In the United States, an estimated 900,000 cases of symptomatic PE occur annually, with incomplete physical recovery often being reported, impacting the quality of life and causing persistent shortness of breath.