Inari Medical FlowTriever device. (Image from Inari Medical) Inari Medical (Nasdaq:NARI) today announced positive results from the prospective PEERLESS trial of the FlowTriever system.
The company designed FlowTriever for device retrieval and aspiration. This system treats pulmonary embolism (PE). FlowTriever non-surgically removes blood clots from peripheral blood vessels. Its uses include the treatment of PE and migrating blood clots within the right atrium. Obtained FDA 510(k) clearance in 2018.
The latest study from Irvine, Calif.-based Inari compared FlowTriever to catheter-directed thrombolytic drugs (CDTs). Co-principal investigator Dr. Wissam Jaber presented the results at Transcatheter Cardiovascular Therapies (TCT) 2024 in Washington, DC.
PEERLESS met its primary composite endpoint with decreased clinical worsening and treatment escalation, fewer ICU admissions, and shorter ICU length of stay for patients using FlowTriever compared to CDT. Patients also recorded faster clinical and hemodynamic recovery, shorter hospital stays, and fewer 30-day readmissions.
“These results are critical in guiding optimal PE treatment decisions and provide strong evidence that FlowTriever has the potential to reduce clinical deterioration and the need for reintervention through more effective early thrombus resolution.” “We provide significant evidence of this,” Dr. Jaber said. “As the only randomized trial evaluating mechanical thrombectomy in PE, thanks to PEERLESS we can now say with confidence that treatment with FlowTriever is safe, effective and superior to CDT. Ta.”
Inari FlowTriever Research Details
PEERLESS enrolled 550 intermediate-risk PE patients at 57 sites worldwide. Patients were randomly assigned to receive either FlowTriever thrombectomy or CDT. In the main cohort, patients with absolute contraindications to thrombolytics were excluded, and few patients with relative contraindications were enrolled.
FlowTriever patients had one-third less clinical worsening and treatment escalation toward relief compared to CDT. Additionally, clinical symptoms and hemodynamics were significantly improved, readmissions were shortened by 24 hours and 30 days, and recovery was accelerated.
In addition, Inari said ICU admissions, ICU length of stay, and length of hospital stay for floattriever patients have been significantly reduced. In the FlowTriever group, there were no patient deaths at discharge or during the 7-day period, no deteriorations related to cardiac arrest, severe atrioventricular block, or respiratory failure, and all-cause mortality at 30-day follow-up was as low as 0.4%. .
“PEERLESS, the first large-scale randomized PE study in more than a decade, reiterates our commitment to research that changes practice and guidelines and sets new standards for clinically meaningful endpoints. ,” said Dr. Thomas Tu, Inari’s chief medical officer. “The results of this study position FlowTriever as a key intervention tool for intermediate-risk PE. PEERLESS is the first in a series of randomized controlled studies identified by Inari et al. and marks the beginning of a golden era in PE research. It will be the beginning of the.
“I would like to thank the dedicated steering committee and researchers who made this trial possible and contributed to its continued impact on patient care.”
