Healthcare company Penumbra has enrolled the first patient in the STORM-PE trial of Lightning Flash, a computer assisted vacuum thrombectomy (CAVT), for the treatment of pulmonary embolism (PE).
Lightning Flash is a device designed to enable a safe, simple, and rapid removal of blood clots from the body.
STORM-PE is a prospective, multi-centre, randomised controlled study that will recruit over 100 participants at up to 20 sites.
Its goal is to assess anticoagulation alone against anticoagulation with Lightning Flash in the treatment of pulmonary embolism.
The STORM-PE trial is intended to improve the outcomes for patients with acute pulmonary embolism by expanding knowledge of the role of CAVT in the management of the potentially fatal condition.
The study is being conducted in collaboration with the PERT Consortium, a multidisciplinary organisation committed to enhancing the care of patients with pulmonary embolism.
Massachusetts General Hospital haematologist and clinical investigator and STORM-PE co-global principal investigator Rachel Rosovsky said: “We have already seen the significant impact Lightning Flash can have on patients.
“The results generated from this pivotal RCT study will provide level 1 evidence of how CAVT compares to current treatment paradigms and will inform us if treatment guidelines need to include this technology as a frontline therapeutic option in patients with intermediate high-risk PE.”
Penumbra’s Lightning Flash can also be used to remove thrombi and emboli from venous and peripheral artery system vessels along with pulmonary embolism treatment.
The CAVT combines hypotube-based Indigo Aspiration Catheters with Lightning Intelligent Aspiration, a computer assisted clot detection technology that can distinguish between clot and blood.
The technology helps minimise blood loss and the need for clot-dissolving medications which may reduce the risk of bleeding complications, the US-based healthcare company said.
Penumbra chief medical officer 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.”
