Inari Medical Announces 6-month FLASH Registry Interim Data Demonstrating Benefits of Lytic-Free Mechanical Thrombectomy in 500 Real-World PE Patients
28 October 2021 - 11:01PM
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, today announced
positive acute and long-term interim results from the first 500
pulmonary embolism (“PE”) patients enrolled in the FlowTriever
Outcomes Registry (“FLASH”). At 48 hours post procedure, the major
adverse event rate and mortality rate were low, at 1.4% and 0.2%,
respectively. None of the deaths or major adverse events were
device related. Collectively, these PE patients experienced
substantial on-table improvements in hemodynamics and symptoms,
which translated to 6-month improvements in cardiac function,
functional status, and quality of life measures. The outcomes were
achieved while limiting utilization of hospital resources, with
less than 4% of patients receiving adjunctive therapy and a median
of 0 days in the ICU post procedure.
FLASH is a prospective, multicenter, single-arm registry
evaluating real-world patient outcomes after treatment of PE with
FlowTriever. The 500-patient interim results were presented at TCT
2021 on October 27th via webcast by Principal Investigator, Catalin
Toma, MD, an Interventional Cardiologist at University of
Pittsburgh Medical Center (UPMC) in Pittsburgh, PA.
“These interim results reinforce the strong safety profile of
the FlowTriever System in real-world PE patients, with substantial
on-table clinical improvements and immediate symptom relief,” said
Dr. Toma. “We believe these 6-month follow-up data suggest that
removal of clot burden without the risks of lytics has potential
positive long-term implications for PE patients, including
strikingly low rates of hospital readmissions, dyspnea, CTED, and
CTEPH. These data suggest that treatment with FlowTriever may
fundamentally improve the natural course of the disease, and that
is tremendously exciting.”
“FlowTriever is quickly becoming the frontline therapy for
intermediate and high-risk PE. FLASH, already the largest
prospective interventional data set in the field of PE, reinforces
the excellent safety, functional improvement, and long-term
outcomes of this approach,” said Thomas Tu, MD, Chief Medical
Officer of Inari Medical. “We believe these data continue to raise
the bar to which existing and new treatments will be held. We
remain committed to venous thromboembolism patients and to
advancing the treatment of this disease through clinical research
and the continued development of purpose-built devices.”
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 marked for the non-surgical removal of
clot from peripheral blood vessels, including for the use in the
treatment of deep vein thrombosis. The 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.
Investor Contact:Westwicke PartnersCaroline
CornerPhone +1-415-202-5678caroline.corner@westwicke.com
Inari Medical (NASDAQ:NARI)
Historical Stock Chart
From Apr 2024 to May 2024
Inari Medical (NASDAQ:NARI)
Historical Stock Chart
From May 2023 to May 2024