Inari Medical’s FlowTriever Will Be Evaluated for Intermediate-High Risk PE in PEERLESS RCT

October 18, 2021—Inari Medical, Inc. announced planned enrollment of the PEERLESS randomized controlled trial (RCT) comparing the clinical outcomes of patients with intermediate-high risk pulmonary embolism (PE) treated with the company’s FlowTriever system versus catheter-directed thrombolysis (CDT).

The FlowTriever system has received FDA 510(k) clearance and CE Mark approval for the treatment of PE and clot in transit in the right atrium. The trial design was presented at the 7th Annual Pulmonary Embolism Symposium, which was sponsored by the Pulmonary Embolism Response Team (PERT) Consortium and held virtually October 14-16.

According to Inari Medical, PEERLESS is a prospective, multicenter trial that will include up to 700 patients and 60 centers in the United States and Europe. The study is composed of two cohorts: a primary randomization cohort of 550 patients; and a secondary nonrandomized cohort of up to 150 patients who cannot be randomized because of an absolute contraindication to thrombolytics.

Carin Gonsalves, MD, and Wissam Jaber, MD, who serve as Global Coprincipal Investigators of the PEERLESS trial, discussed the trial in the company’s press release. Dr. Gonsalves is Professor of Radiology and Co-Director of the Division of Interventional Radiology at Thomas Jefferson University in Philadelphia, Pennsylvania. Dr. Jaber is PERT Director, and Director of the Cardiac Catheterization Lab at Emory University Hospital in Atlanta, Georgia.

“Historically, due to the major bleeding associated with lytic therapy, physicians needed to carefully weigh a patient’s risk of death against the risk of intervention, reserving advanced treatment for only the sickest of PE patients,” commented Dr. Gonsalves. “By offering patients immediate symptom relief upon removal of significant clot burden without the risks of lytics, the potential for bloodless thrombectomy with the FlowTriever system has fundamentally altered the PE treatment landscape, challenging physicians to rethink risk stratification and the goals of intervention.”

Dr. Jaber stated, “PEERLESS is the first ever RCT to compare mechanical thrombectomy to CDT for the treatment of PE and aims to provide definitive data on interventional treatment options for these patients. The primary outcome for the trial is a hierarchical composite of outcomes including mortality, major bleeding events, clinical deterioration, and length of stay in the intensive care unit. These are highly relevant endpoints for patients and for the hospital systems that care for them.”