The multicentre, global, prospective, randomised controlled trial (RCT) is designed to compare the outcomes of intermediate-risk acute PE with the FlowTriever System versus those being treated with conventional anticoagulation therapy alone.
Dr William Matthai Jr, who serves as the director of clinical cardiology research and professor of clinical medicine (Cardiovascular Medicine) at Penn Presbyterian Medical Center at the University of Pennsylvania, US, enrolled the initial patient.
Matthai said: “Despite advances in mechanical thrombectomy, anticoagulation alone remains the standard of care. This trial aims to generate definitive evidence to influence PE treatment guidelines worldwide.”
Claimed to be the largest study of its kind, PEERLESS II will enrol up to 1,200 randomised patients at a maximum of 100 global centres.
The study is being conducted simultaneously with the current PEERLESS RCT trial, which is evaluating FlowTriever in comparison with catheter-directed thrombolysis.
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The two trials seek to produce clinical evidence to establish FlowTriever as the optimal therapy for intermediate-risk PE patients.
Inari CMO Dr Thomas Tu said: “Inari is actively enrolling three RCTs: PEERLESS, PEERLESS II and DEFIANCE, demonstrating our relentless commitment to guideline-changing research aimed at ultimately improving patient outcomes.
“With the commitment of our dedicated investigators, we look forward to expedited enrollment to get us closer to changing the standard of care.”
The company has received 510(k) clearance from the US Food and Drug Administration (FDA) and CE marking for the non-surgical removal of clots from peripheral blood vessels, including treatment for pulmonary embolism and clots in transit in the right atrium.
At the start of this month, Inari reached an agreement to acquire medical device company LimFlow in a deal valued at up to $415m.