Imperative Care Announces FDA Clearance and Initial Cases of the Zoom 6F Insert Catheters, the First Insert Catheters Built for Stroke
2024年7月17日 - 9:00PM
ビジネスワイヤ(英語)
- New technology offered in three unique shapes
expands the company’s comprehensive stroke system, allowing
physicians to achieve fast and consistent intracranial access
Imperative Care, Inc., today announced U.S. Food and Drug
Administration (FDA) 510(k) clearance of its Zoom™ 6F Insert
Catheters, the company’s latest innovation in elevating stroke care
and the first insert catheters developed specifically for ischemic
stroke procedures. The company also announced the successful
completion of the first case with the Zoom 6F Insert Catheters,
which was performed by Dr. Dana Tomalty at Huntsville Hospital in
Huntsville, Alabama.
Based on physician feedback, the new Zoom 6F Insert Catheters
were developed to be more supportive, more torque-able and longer
than current vessel selection devices and are offered in three
stroke-specific shapes. These features are designed for faster
vessel selection and uncompromised delivery of the company’s
comprehensive 0.088” intracranial access technologies – Zoom 88,
Zoom 88 Support and Zoom RDL – to the intracranial anatomy.
“Insert catheters used for stroke today are diagnostic catheters
that were designed for cardiovascular access more than 30 years
ago. The Zoom 6F Insert Catheters bring physicians the modern-day
tools and technologies that will allow them the opportunity to best
care for their patients, bridging the innovation gap of 30 years to
today’s standards for stroke treatment,” said Ariel Sutton, General
Manager of Imperative Care’s Stroke Business.
“We are deeply committed to working closely with physicians to
identify critical gaps in stroke care and providing innovative
solutions that bring meaningful benefits to their patients. The
introduction of the Zoom 6F Insert Catheters demonstrates our core
tenet of clinical partnership, which puts the perspectives of
front-line physicians at the center of our research and development
process,” added Sutton.
The Zoom 6F Insert Catheter portfolio consists of the Zoom SIM,
Zoom VRT, and Zoom VTK technologies – all unique in their shape,
construction and length with the goal of helping physicians achieve
faster and more reliable intracranial access in a wide range of
patient anatomies.
In the first case performed by Dr. Tomalty, the Zoom SIM Insert
Catheter was used to quickly select the target vessel and provide
.088” intracranial access from the femoral artery with Zoom 88 in a
patient with a challenging anatomy and distal left M2 occlusion.
The Zoom SIM provided added stability to navigate Zoom 88 far into
the brain and access the clot more quickly. Dr. Tomalty then used
both Zoom 71 and Zoom 35 to aspirate and remove the clot in only 10
minutes from puncture to reperfusion, resulting in a complete TICI
3 revascularization.
“In my experience, navigating the aortic arch can pose a
significant challenge in patients with more tortuous anatomy. Due
to the unique design and capabilities of the Zoom 6F Insert
Catheters, I believe the use of these technologies will help
mitigate this challenge and take minutes off my stroke thrombectomy
times, allowing me to get the clot out faster,” Tomalty said.
Clinical evidence shows that the Zoom Stroke Solution can help
physicians achieve better reperfusion and faster cases with fewer
devices in stroke procedures1,2. Imperative Care is the first
company to offer a comprehensive portfolio designed for physicians
to rapidly achieve intracranial access from the puncture site to
quickly reach the target location and diagnose the clot location,
allowing the physician to deliver the ideal aspiration thrombectomy
catheter to completely remove the clot. This allows the physician
to achieve fast and effective reperfusion for the best possible
outcome for the patient.
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 catheter3 and are
designed to enable smooth tracking through challenging vasculature.
For complete product information, including indications,
contraindications, warnings, precautions and adverse events, visit:
http://bit.ly/2Vx0Qcf
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.
1. Al-Kawaz M, Milburn J, Tomalty D, et al Higher intracranial
positioning of 8fr-guide catheter improves efficacy of aspiration
thrombectomy in large vessel occlusion stroke Journal of
NeuroInterventional Surgery 2023;15:A131. 2. Milburn J, Vidal G,
Gulotta P, et al Intracranial large bore guide catheter placement
is associated with excellent reperfusion: a single institution
experience Journal of NeuroInterventional Surgery 2022;14:A210. 3.
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