Penumbra has completed subject enrolment in the multi-centre, randomised controlled trial, STORM-PE, which assesses the computer-assisted vacuum thrombectomy (CAVT) using the company鈥檚 Lightning Flash plus anticoagulation, in treating acute intermediate-high risk pulmonary embolism.
The trial aims to assess the efficacy and safety of treating these patients with only anticoagulation against anticoagulation + CAVT with the Indigo Aspiration System.
Carried out in collaboration with the Pulmonary Embolism Response Team聽(PERT) Consortium, the trial enrolled 100 subjects. It aims to offer evidence on the role of CAVT in improving right heart function and clinical outcomes for critically ill individuals.
The endpoints include changes in the right ventricle/left ventricle (RV/LV) ratio evaluated by computed tomography pulmonary angiography (CTPA) at 48 hours, major adverse events within seven days, and functional outcomes and quality of life evaluations at 90 days.
Penumbra’s chief medical officer James Benenati said: 鈥淭his is an important milestone that underscores Penumbra鈥檚 commitment to transforming care for patients with pulmonary embolism.
鈥淭he trial successfully randomised patients well ahead of schedule thanks to the dedication of our clinical partners and the tireless efforts of our internal teams.鈥�
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By GlobalDataPenumbra noted that its Lightning Flash portfolio addresses venous and pulmonary thrombus, featuring the latest dual clot detection algorithms utilising the pressure and flow-based processes to identify the flow and clots of blood.
STORM-PE co-global principal investigator and Massachusetts General Hospital haematologist Rachel Rosovsky said: 鈥淧ulmonary embolism remains a leading cause of cardiovascular morbidity and mortality, yet treatment strategies for intermediate-high risk patients are not well defined.鈥�
The thrombectomy company develops solutions for medical conditions such as ischemic stroke, venous thromboembolism, and acute limb ischemia.
Penumbra recently introduced the Ruby XL System, a detachable embolisation coil, which has also secured clearance from the US Food and Drug Administration (FDA).
