Inari Medical Announces Randomized Controlled Trial Evaluating Clinical Outcomes of the FlowTriever® System in Pulmonary Embolism Patients
October 18 2021 - 8:00AM
Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device
company focused on developing products to treat and transform the
lives of patients suffering from venous diseases, 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 United States 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.”
About Inari Medical, Inc.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.
Investor Contact:Westwicke PartnersCaroline
CornerPhone +1-415-202-5678caroline.corner@westwicke.com
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