Sam Brusco, Associate Editor11.28.23
Inari Medical announced the first patient enrollment in its PEERLESS II study.
The prospective, global, multi-center randomized controlled trial (RCT) will compare the outcomes of intermediate-risk acute pulmonary embolism (PE) patients treated with Inari’s FlowTriever against those treated with anticoagulant therapy alone.
The first patient was enrolled by Dr. William H. Matthai, Jr., Director of Clinical Cardiology Research and Professor of Clinical Medicine (Cardiovascular Medicine) at Penn Presbyterian Medical Center at the University of Pennsylvania.
"PEERLESS II is challenging the most commonly administered first-line therapy for PE around the world,” Dr. Matthai told the press. “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."
The largest study of its kind, PEERLESS II will enroll up to 1,200 patients at up to 100 global centers. The study is running alongside the currently enrolling PEERLESS RCT, which is comparing FlowTriever to catheter-directed thrombolysis.
Both trials have the goal of generating clinical evidence to move the field forward and establish FlowTriever as the best therapy for intermediate-risk PE patients, Inari 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,” said Dr. Thomas Tu, Inari’s chief medical officer. “With the commitment of our dedicated investigators, we look forward to expedited enrollment to get us closer to changing the standard of care."
Earlier this month, Inari closed its acquisition of LimFlow, maker of the TADV system to treat chronic limb-threatening ischemia.
The prospective, global, multi-center randomized controlled trial (RCT) will compare the outcomes of intermediate-risk acute pulmonary embolism (PE) patients treated with Inari’s FlowTriever against those treated with anticoagulant therapy alone.
The first patient was enrolled by Dr. William H. Matthai, Jr., Director of Clinical Cardiology Research and Professor of Clinical Medicine (Cardiovascular Medicine) at Penn Presbyterian Medical Center at the University of Pennsylvania.
"PEERLESS II is challenging the most commonly administered first-line therapy for PE around the world,” Dr. Matthai told the press. “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."
The largest study of its kind, PEERLESS II will enroll up to 1,200 patients at up to 100 global centers. The study is running alongside the currently enrolling PEERLESS RCT, which is comparing FlowTriever to catheter-directed thrombolysis.
Both trials have the goal of generating clinical evidence to move the field forward and establish FlowTriever as the best therapy for intermediate-risk PE patients, Inari 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,” said Dr. Thomas Tu, Inari’s chief medical officer. “With the commitment of our dedicated investigators, we look forward to expedited enrollment to get us closer to changing the standard of care."
Earlier this month, Inari closed its acquisition of LimFlow, maker of the TADV system to treat chronic limb-threatening ischemia.