Inari Medical Announces Interim Two-Year Results from the ClotTriever CLOUT Registry
March 12 2024 - 3:05PM
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 and other diseases,
announced positive two-year interim results from the CLOUT
registry. The data was presented at the American Venous Forum
meeting by principal investigator, David Dexter, MD, FACS, a
vascular surgeon at Sentara Vascular Specialists in Norfolk,
Virginia.
The interim results are the largest prospective, multi-center
two-year dataset in deep vein thrombosis (DVT) since the ATTRACT
trial and confirm the excellent safety, effectiveness, and
long-term outcomes of the ClotTriever system in real-world DVT
patients. Patients had low incidence of independently adjudicated
safety events related to rethrombosis, with only 5.0% and 8.4% at
30-days and 6 months, respectively. In the interim analysis, 228
patients completed their two-year follow-up visit. Patients had
significant and sustained improvement in post-thrombotic syndrome
(PTS) over the follow-up period, with only 7.3% moderate-severe PTS
at two years. The PTS rates reported in CLOUT are significantly
lower than those from historical DVT studies such as ATTRACT and
CAVA, which reported moderate-severe PTS rates ranging from
18-24%.
“With third-party adjudication of all safety events in this
robust, large dataset, ClotTriever has a strong safety profile. And
the longer-term results are suggestive of sustained benefit through
a critical window when longer-term sequalae typically manifest in
DVT patients,” said Dr. Dexter. “The low PTS rate that continues to
improve over time is a testament to the safety and effectiveness of
wall-to-wall thrombus removal with ClotTriever.”
“This data continues to reinforce the strong safety and
effectiveness profile of the ClotTriever system, which is not only
the most utilized, but also the most studied thrombectomy device in
DVT,” said Dr. Thomas Tu, Inari’s Chief Medical Officer. “We are
committed to generating best-in-class clinical data. This includes
our currently enrolling randomized controlled trial, DEFIANCE,
which will compare outcomes after ClotTriever treatment vs.
anticoagulation alone. No other company is pursuing this level of
research in VTE. In the treatment of DVT, clinical data does
matter. We remain committed to establishing the ClotTriever and
FlowTriever systems as standard of care for deep vein thrombosis
and pulmonary embolism (PE) patients.”
PTS Rates in Context:
|
ClotTriever CLOUT RegistryInterim results
(n=228) |
ATTRACT Anticoagulation Arm (n=236) |
ATTRACT Intervention Arm (n=258) |
CAVA Anticoagulation Arm (n=58) |
CAVA Intervention Arm (n=62) |
2-Year PTS |
19.9% |
36.0% |
30.6% |
44.8%* |
30.6%* |
2-Year Moderate-Severe PTS |
7.3% |
24.0% |
18.2% |
24.1%* |
22.6%* |
*Median follow-up 39.0 months
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 underserved 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.
References:
ATTRACT: Vedantham, et al. N Eng J Med. 2017. CAVA: Notten, et
al. J Am Heart Assoc. 2021
Investor Contact:John Hsu, CFAVP, Investor
Relations949-658-3889IR@inarimedical.com
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