Magneto Thrombectomy Solutions (Magneto), a medical devices company developing thrombectomy solutions for the treatment of ischaemic stroke and pulmonary embolism, presented successful first-in-human (FIH) results showing safety and feasibility of the eTrieve system, a catheter based on electric fields for removing blood clots, in patients with acute pulmonary embolism (PE).
The data, presented at Biomed Israel 2022, the international life science and healthtech conference in Israel (May 10–12, Tel Aviv), showed a significant reduction in right ventricle/left ventricle ratio and alleviation of PE-associated symptoms.
“Magneto provides intermediate and high-risk PE patients with a unique solution for safely and effectively removing large clots blocking the arteries in the lungs,” said Piotr Musialek (John Paul II Hospital, Krakow, Poland) and an investigator in the study. “The combination of a large-diameter ‘vacuum cleaner’ with electro-mechanical thrombus extraction, allows an immediate resolution of dyspnoea and swift recovery of the cardio-respiratory system.”
The prospective, single-arm, multicentre first-in-human study assessed the initial safety and performance of eTrieve in treating patients with acute PE. The study enrolled 10 participants across three sites in Denmark and Poland. Results show that the procedure, performed under light sedation only, was safe with no device related complications. The primary performance endpoint was also met, with significant reduction of right ventricle to left ventricle volume 48 hours post-intervention. Significant clot volumes were removed, and alleviation of PE-associated symptoms was demonstrated. The catheter removed both fresh and organised clots and successfully removed blood clots of all sizes and types, from locations that could not have been safely reached using other techniques.
Prof. Asger Andersen (Aarhus University Hospital, Aarhus, Denmark), principal investigator of the study, added, “large bore aspiration of central clots with possibility to retrieve segmental clots with the eTrieve catheter, optimises the possibility for complete pulmonary revascularisation in acute PE.”