Inari Medical Announces First Patient Enrollment in PEERLESS II Randomized Controlled Trial (RCT)
27 Novembre 2023 - 10:20PM
Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device
company with a mission to treat and transform the lives of patients
suffering from venous and other diseases, today announced the first
patient enrollment in the PEERLESS II study. This prospective,
global, multi-center randomized controlled trial (“RCT”) compares
the outcomes of intermediate-risk acute pulmonary embolism (“PE”)
patients treated with the FlowTriever
® System
against those treated with traditional anticoagulation therapy
alone. The first patient was enrolled by Dr. William H. Matthai,
Jr., Director of Clinical Cardiology Research and Professor of
Clinical Medicine (Cardiovascular Medicine) at Penn Presbyterian
Medical Center at the University of Pennsylvania.
"PEERLESS II is challenging the most commonly
administered first-line therapy for PE around the world,” said Dr.
Matthai. “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."
PEERLESS II is the largest study of its kind and
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 move the field forward and establish FlowTriever
as the optimal therapy for intermediate-risk PE patients.
"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,” added Global Principal
Investigator Dr. Jay Giri, Director of the Cardiovascular
Catheterization Laboratories Associate Director and Associate
Professor of Medicine at the Hospital of the University of
Pennsylvania. “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."
"Inari is actively enrolling three RCTs:
PEERLESS, PEERLESS II and DEFIANCE, demonstrating our relentless
commitment to guideline-changing research aimed at ultimately
improving patient outcomes,” said Dr. Thomas Tu, Inari’s Chief
Medical Officer. “With the commitment of our dedicated
investigators, we look forward to expedited enrollment to get us
closer to changing the standard of care."
About the
FlowTriever® SystemThe
FlowTriever® system is 510(k)-cleared by FDA and CE marked for the
non-surgical removal of clot from peripheral blood vessels,
including for the use in the treatment of pulmonary embolism and
clot in transit in the right atrium.
About Inari Medical,
Inc.Patients first. No small plans. Take care of each
other. These are the guiding principles that form the ethos of
Inari Medical. We are committed to improving lives in extraordinary
ways by creating innovative solutions for both unmet and
underrecognized health needs. In addition to our purpose-built
products, we leverage our capabilities in education, clinical
research, and program development to improve patient
outcomes. We are passionate about our mission to establish our
treatments as the standard of care for venous thromboembolism and
beyond. We are just getting started.
Investor Contact:John Hsu, CFAVP, Investor
Relations949-658-3889IR@inarimedical.com
Image 1: PEERLESS II RCT Comparing Mechanical
Thrombectomy to Conservative Medical Management
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/29d522ae-d14c-4c85-a938-b60d645eb806
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