Penumbra has enrolled the first patient in the STORM-PE study, which is designed to assess anticoagulation alone against anticoagulation plus Lightning Flash to treat pulmonary embolism (PE).
In collaboration with the PERT Consortium, the multicentre, prospective, and randomised controlled trial intends to deeply understand the role of computer-assisted vacuum thrombectomy (CAVT) in managing acute PE.
The study will enrol up to 100 participants at up to 20 centres.
The Lightning Flash mechanical thrombectomy system is intended for removing emboli and thrombi from vessels of the peripheral arterial and venous systems.
It integrates hypotube-based Indigo Aspiration Catheters with Lightning Intelligent Aspiration technology for reducing blood loss and the need for clot-dissolving drugs.
Lightning Intelligent Aspiration is a computer-assisted clot detection technology, which holds the potential to differentiate between clot and blood.
Penumbra CMO James Benenati said: “Our commitment to clinical research and innovation enables us to lead with insight and continue to pioneer interventional therapies that have a significant impact on patients such as our CAVT technologies.
“In partnership with PERT Consortium, we are committed to generating robust clinical evidence that will help transform care so patients, especially those with serious conditions such as PE, can return home quickly and live fully.”
PE poses a life-threatening risk, as 10%-30% of individuals may die within one month of diagnosis. In the US, approximately 900,000 cases of symptomatic PE occur each year.
STORM-PE co-global principal investigator and Massachusetts General Hospital haematologist and clinical investigator Rachel Rosovsky said: “STORM-PE is the first head-to-head trial comparing anticoagulation, the mainstay and standard of care for treating acute PE, to CAVT.”
In January this year, Penumbra announced the launch of its Lightning Flash system, which is powered by the Penumbra ENGINE.
Lightning Flash is part of the Penumbra Indigo System within the Lightning portfolio and can detect blood clots and flow using a combination of pressure and flow-based algorithms.
