Author: Dr. Robert Lookstein

Institution: Professor of Radiology and Surgery, Mount Sinai School of Medicine, New York, USA

Summary

This presentation discusses the use of the 24F Flowtriever and 16F Lightning Flash mechanical thrombectomy devices in the treatment of acute pulmonary embolism (PE). Based on the latest clinical studies and trial data, these devices demonstrate high success rates and significant clinical improvements in acute PE patients, especially in high-risk cases. Trials such as PEERLESS II and STORM-PE further validate the safety and efficacy of these technologies.

Flowtriever and Lightning Flash Systems

• Flowtriever System: Flowtriever is a large-bore mechanical thrombectomy system designed for the non-surgical removal of thrombi from blood vessels. The system includes a flow restoration catheter, suction catheter, and retrieval suction device for treating emboli in pulmonary and peripheral vessels.

• Lightning Flash System: Lightning Flash is a low-profile, high-efficiency thrombectomy system that utilizes pressure and flow-based algorithms for rapid thrombus removal. This system, featuring computer-assisted thrombectomy (CAVT) technology, is designed to tackle thrombi in complex anatomical structures.

Clinical Trial Data

• PEERLESS II Trial:This trial compares the efficacy of Flowtriever with anticoagulation therapy alone in treating acute PE. The trial includes 1,200 intermediate-to-high-risk acute PE patients, with results showing that the Flowtriever group had lower 30-day all-cause mortality, clinical deterioration, and rehospitalization rates compared to the anticoagulation group.

• STORM-PE Trial: This study, using a 1:1 randomization, compares mechanical thrombectomy with anticoagulation therapy in intermediate-to-high-risk acute PE patients. Preliminary results show that patients using Lightning Flash had a 27% improvement in the right ventricle/left ventricle (RV/LV) ratio within 48 hours and a low major adverse event (MAE) rate of just 2.4%.

Case Studies and Results

• Clinical Case 1:The 24F Flowtriever system successfully removed bilateral pulmonary emboli, with the patient’s right ventricular function significantly improving within 48 hours and no major post-operative complications.

• Clinical Case 2: In a high-risk acute PE patient, the Lightning Flash system completed thrombectomy in 24 minutes, significantly improving the RV/LV ratio, with the patient’s functional status markedly improved within 90 days.

Conclusion

1. The Flowtriever and Lightning Flash systems have shown excellent efficacy in treating acute pulmonary embolism, particularly in high-risk and complex cases.

2. Large-scale clinical trials such as PEERLESS II and STORM-PE have validated the safety and efficacy of these devices, highlighting their potential to improve patient outcomes.

3. Future research will explore the use of these technologies in other vascular embolic conditions and further enhance their functionality and applicability.

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