Inari Medical Announces Presentation of Positive 30-Day Follow-Up Results from First Patients in Real World FLASH Registry
November 13 2020 - 10:00AM
Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a commercial-stage
medical device company focused on developing products to treat and
transform the lives of patients suffering from venous diseases,
today announced follow-up results of the first 230 patients
enrolled in its FLASH study. FLASH is a real world registry
to study the FlowTriever system in intermediate- and high-risk
pulmonary embolism (“PE”) patients. The results were strongly
positive. Just one death (0.4%) was reported at 30
days. By contrast, the national PERT Consortium® Quality
Database recently showed 30-day mortality rates of 25.9% and 6.1%
for high- and intermediate-risk PE patients. In addition, the
FLASH Registry showed a readmission rate of 6.7%, compared to the
nearly 25% readmission rate shown in the PERT Database.
Efficacy data were equally compelling, showing normalization or
near normalization in a battery of hemodynamic variables like
pulmonary artery pressure, RV/LV ratio, and heart rate, as well as
dyspnea (shortness of breath) metrics.
FLASH is a 500-patient prospective, multicenter, single-arm
registry evaluating real world patient outcomes after treatment of
PE with FlowTriever. Interim data were obtained across 19 US sites,
and results were presented virtually by National Principal
Investigator, Catalin Toma, MD, Director of Interventional
Cardiology at UPMC Heart & Vascular Institute in Pittsburgh, PA
at the American Heart Association (“AHA”) Scientific Sessions
2020.
These data follow the presentation of equally compelling acute
data from the same patient set delivered two weeks ago at the
annual TCT meeting. The acute results showed, at 48 hours, no
deaths, no cardiac injuries, no pulmonary injuries, no
procedure-related clinical deteriorations, and no intracranial
hemorrhages in this highly compromised PE patient population.
The TCT data also showed clinically and statistically significant
improvement in hemodynamic parameters while the patient was still
on the table. Post-procedure median ICU stay was 0
days. The new FLASH data released at AHA extends the study
follow-up period to 30 days and demonstrates the durability of
these acute results with continued improvement in outcomes over
time.
“FLASH has shown us that PE patients experience symptom relief
and improved cardiac function immediately upon removal of
significant clot burden. These outcomes continue to improve
over time. In fact, for a high percentage of these patients,
measurements for dyspnea, right heart strain, pulmonary artery
pressure and heart rate actually normalized after FlowTriever
thrombectomy. We believe this suggests that removal of large
clot burden with the FlowTriever system not only has an important
impact acutely, but might have an important positive effect on long
term implications of PE, like CTED and CTEPH,” said Dr. Toma.
“With over 60% of patients in FLASH having no contraindication
to lytics, the study data suggests that FlowTriever is emerging as
a frontline therapy for intermediate and high-risk PE patients,
regardless of patient eligibility for other treatment
options. PE care pathways are evolving,” said Thomas Tu, MD,
Chief Medical Officer of Inari Medical. “Venous thromboembolism
(“VTE”) patients are central to everything that we do at Inari, and
we remain committed 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 commercial-stage 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 the FDA for
the treatment of deep vein thrombosis. The FlowTriever system is
510(k)-cleared by the FDA for the treatment of pulmonary
embolism.
Investor Contact:Westwicke PartnersCaroline
CornerPhone +1-415-202-5678 caroline.corner@westwicke.com
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