Inari Commences PEERLESS II RCT of FlowTriever in Intermediate-Risk PE

November 27, 2023—Inari Medical, Inc. announced that the first patient has been enrolled in the PEERLESS II randomized controlled trial (RCT).

According to the company, the PEERLESS II RCT is a prospective global multicenter study comparing the outcomes of intermediate-risk acute pulmonary embolism (PE) patients treated with the company’s FlowTriever system versus patients treated with anticoagulation therapy alone.

PEERLESS II will include up to 1,200 randomized 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 aim to generate the high-quality clinical evidence needed to establish FlowTriever as an optimal therapy for intermediate-risk PE patients, stated the company.

The FlowTriever system has received FDA 510(k) clearance and European CE Mark approval for the nonsurgical removal of clot from peripheral blood vessels, including for use in the treatment of PE and clot in transit in the right atrium.

The first patient treated in PEERLESS II was enrolled by William H. Matthai, Jr, MD, who is Director of Clinical Cardiology Research and Professor of Clinical Medicine (Cardiovascular Medicine) at Penn Presbyterian Medical Center at the University of Pennsylvania in Philadelphia, Pennsylvania. The PEERLESS II RCT’s global principal investigator is Jay Giri, MD. Dr. Giri is Director of the Cardiovascular Catheterization Laboratories, Associate Director and Associate Professor of Medicine at the Hospital of the University of Pennsylvania.

“PEERLESS II is challenging the most commonly administered first-line therapy for PE around the world,” commented Dr. Matthai in the company’s press release. “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.”

Dr. Giri added, “PE is a leading cause of cardiovascular death, and this first patient enrollment represents an important milestone in the evolution of care for this disease. The rigorous trial design, including meaningful patient-centric endpoints and independent adjudication of all safety events, lays the groundwork for this landmark study to impact future PE treatment decisions. Thank you to the PEERLESS II steering committee and clinical staff for helping us get the first patient enrolled.”