Late-Breaking Data Presented at SNIS Suggest
Lower Rates of Rescue Therapy Than Prior Thrombectomy Trials; Rapid
Reperfusion Time; High Rates of Reperfusion
Imperative Care, Inc. today announced that late-breaking data
from the Imperative Trial were presented at the Society of
NeuroInterventional Surgery (SNIS) 2024 21st Annual Meeting in
Colorado Springs. The prospective, multi-center clinical trial
evaluated the clinical benefits of the Zoom Reperfusion System,
including aspiration with 0.088” catheters for the treatment of
ischemic stroke.* Data from the clinical trial were presented by
Dr. William Mack, M.D., Professor of Neurosurgery at the Keck
School of Medicine, University of Southern California and
Co-Principal Investigator of the Imperative Trial.
“At Imperative Care, we are focused on developing technologies
designed for intracranial access, with the goal of enabling
physicians to perform better procedures with faster clot removal
using fewer devices as demonstrated in previous clinical studies of
the Zoom Stroke Solution1, and now further supported by initial
findings from the Imperative Trial. These data suggest this
approach is poised to be better across a number of endpoints,” said
Ariel Sutton, General Manager of Imperative Care’s Stroke business.
“We look forward to our continued efforts to elevate stroke care
through our sustained commitment to clinical evidence and
meaningful innovation with the goal of improving patient
outcomes.”
The study evaluated 260 patients who met inclusion and exclusion
criteria and were treated across 26 U.S. institutions from October
2021 to March 2024. Pre-specified performance goals were
established in conjunction with the FDA and 254 patients completed
follow-up at 90 days.
Results from the trial demonstrated the core-lab adjudicated
rate of mTICI ≥2B reperfusion within ≤3 passes without the use of
any additional thrombectomy devices as rescue therapy was achieved
in 82.2% of patients (213/259), which is similar to prior trials
used to support 510(k) clearance for reperfusion indications
(82.4%, 1,832/2,246).2 Stent retrieval rescue therapy achieved
mTICI ≥2B reperfusion in only 5.5% of cases (13/238).
Data showed median time from groin puncture to mTICI ≥2B
reperfusion using the Zoom Reperfusion System was 19 minutes.
Additionally, the core-lab adjudicated rate of symptomatic
intracranial hemorrhage was 2.3% (6/260), lower than the rate of
prior trials (4.7%, 116/1,777)3, and the rate of independently
adjudicated dissection and vessel perforation was 1.2% (3/260),
similar to prior trials (1.3%, 14/933).4
“The observed data showed all three pre-specified performance
goals were met. These data suggest a lower rate of rescue therapy
than prior thrombectomy trials and may demonstrate that
intracranial positioning of a super-large bore catheter could
influence or reduce the need for stent retrieval rescue therapy as
well as decrease costs,” said Dr. Mack. “Additionally, the very low
rate of symptomatic intracranial hemorrhage coupled with high rates
of reperfusion are promising. I look forward to the potential
implications for my practice and the patients I treat.”
“We are pleased with the preliminary results of the Imperative
Trial,” said Fred Khosravi, Chairman and CEO of Imperative Care.
“Our mission to elevate care for patients suffering from stroke and
other devastating vascular diseases extends beyond the operating
room. We are happy to advance the field through our commitment to
validating our innovations with robust clinical data.”
About the Zoom Stroke Solution
The Zoom Stroke Solution is the complete stroke system from
access through reperfusion for fast and effective clot removal in
patients presenting with acute ischemic stroke. The system includes
a comprehensive access portfolio consisting of the Zoom 6F Insert
Catheters, Zoom 88 and Zoom 88 Support Large Distal Platform, Zoom
RDL Radial Access Platform, four vessel-matched Zoom Aspiration
Catheters, Zoom Pump, Zoom POD and accessories. All Zoom Aspiration
Catheters are designed with the unique TRX™ Tip, which provides 15%
greater clot engagement area at the tip of the catheter5 and are
designed to enable smooth tracking through challenging vasculature.
For complete product information, including indications,
contraindications, warnings, precautions and adverse events, visit:
https://bit.ly/3yWkfEJ.
About Imperative Care, Inc.
Imperative Care is a commercial-stage medical technology company
researching and developing connected innovations to elevate care
for people affected by devastating vascular diseases such as stroke
and pulmonary embolism. The company is focused on addressing
specific gaps in treatment and care to make an impact across the
entire patient journey. Imperative Care is based in Campbell,
Calif. https://imperativecare.com.
*Caution: Investigational Device – Limited by Federal law to
investigational use. Aspiration with Zoom 88 is not cleared.
1. Milburn J, Gulotta P, Fennell V, et al. Angled tip
reperfusion catheters are associated with quicker access to final
recanalization and reduced utilization of stent retrievers and
secondary catheter usage in patients with emergent large vessel
occlusion, which may reduce procedure cost. Journal of
NeuroInterventional Surgery 2022;14:A198.
2. Meta-Analysis of 510(k) data from SWIFT PRIME, Penumbra 3D,
ARISE II, TIGER, ETIS, and PROST trials. Data on file.
3. Meta-Analysis of SWIFT PRIME, MR CLEAN De Novo 510(k) data,
Penumbra 3D, ARISE II, and ETIS. Data on file.
4. Meta-Analysis of SWIFT PRIME, MR CLEAN De Novo 510(k) data,
Penumbra 3D, ARISE II, and PROST. Data on file.
5. Vargas J, Blalock J, Venkatraman A, et al. Efficacy of
beveled tip aspiration catheter in mechanical thrombectomy for
acute ischemic stroke. Journal of NeuroInterventional Surgery
2021;13:823-826.
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Investor Contact: Matt Garrett, CFO Imperative Care, Inc.
408-476-1672 mgarrett@imperativecare.com
Media Contact: Lara Lingenbrink Imperative Care, Inc.
858-525-1414 llingenbrink@imperativecare.com