Inari Medical Announces Randomized Controlled Trial Evaluating Clinical Outcomes of the FlowTriever System in Pulmonary Embolism Patients
Inari Medical, Inc. recently announced planned enrollment of the PEERLESS trial. PEERLESS is a new randomized controlled trial (RCT) comparing the clinical outcomes of patients with intermediate-high risk pulmonary embolism (PE) treated with the FlowTriever System versus catheter-directed thrombolysis (CDT). The trial design was presented at the 7th Annual Pulmonary Embolism Symposium, sponsored by the PERT Consortium.
PEERLESS is a prospective, multi-center trial that will include up to 700 patients and 60 centers in the US and Europe. The study consists of a primary randomization cohort of 550 patients, and for patients who cannot be randomized due to an absolute contraindication to thrombolytics, a secondary non-randomized cohort of up to 150 patients.
“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,” said Global Co-Principal Investigator, Dr. Carin Gonsalves, Professor of Radiology and Co-Director of the Division of Interventional Radiology at Thomas Jefferson University in Philadelphia, PA. “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.”
“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,” added Global Co-Principal Investigator, Dr. Wissam Jaber, PERT Director, and Director of the Cardiac Cath Lab at Emory University Hospital in Atlanta, GA. “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.”
“With active engagement on over 30 investigator-initiated studies, and 1,000 patients currently enrolled in our three ongoing VTE registries – CLOUT, FLASH, and FLAME – our clinical pipeline is as robust as ever,” said Bill Hoffman, Inari’s Chief Executive Officer. “PEERLESS opens a new chapter in our clinical story, answering the calls of physicians around the world for randomized control data to inform guidelines and redefine VTE treatment pathways around the world.”
Inari Medical, Inc. is a medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases. Inari has developed two minimally invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purpose-built its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE: deep vein thrombosis and pulmonary embolism. The ClotTriever system is 510(k)-cleared by FDA and CE Mark approved for the treatment of deep vein thrombosis. The FlowTriever system is 510(k)-cleared by FDA and CE Mark approved for the treatment of pulmonary embolism and clot in transit in the right atrium.
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