Inari Medical has unveiled planned recruitment for its third randomised controlled trial (RCT) in venous thromboembolism (VTE) for the evaluation of its FlowTriever system.

The company has revealed the trial design for the PEERLESS II study at the Society for Cardiovascular Angiography and Interventions (SCAI) 2023 Scientific Sessions in Phoenix, Arizona, US.

Inari chief medical officer Dr Thomas Tu said: “With over 1,700 patients across PEERLESS and PEERLESS II, Inari is now set to enrol more PE RCT patients than all industry and non-industry RCTs combined.

“Inari’s three RCTs in VTE all aim to study meaningful, patient-centric clinical endpoints. We are thankful for the partnership of our Steering Committee and the commitment of our investigators dedicated to generating high-quality clinical evidence.”

PEERLESS II is a multi-centre, prospective, global RCT designed to compare the clinical outcomes of the FlowTriever system versus anticoagulation alone in intermediate-risk pulmonary embolism (PE) patients.

The company will recruit up to 1,200 patients who will be studied during the trial, which is planned to take place at up to 100 centres across the world.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Global principal investigators Dr Jay Giri, Dr Frances Mae West, Professor Bernhard Gebauer and Professor Felix Mahfoud will lead the study.

In a statement, Dr Giri said: “PEERLESS II is a ground-breaking trial in terms of its robust size, randomised design and potential to shape PE treatment guidelines.

“The primary outcome for the trial is a hierarchical composite of clinical outcomes including mortality, clinical deterioration, hospital re-admission and dyspnea.

“These meaningful endpoints go beyond historical surrogate measures such as RV/LV ratio to definitively answer critical questions about intervention in PE with the FlowTriever system.”