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Two-for-one Stroke Thrombectomy:A novel Dual DAC to enhance navigability, lumen size, aspiration efficiency, and persistent flow arrest in mechanical thrombectomy

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NS129448-01A1
Agency Tracking Number: R41NS129448
Amount: $499,765.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 105
Solicitation Number: PA22-178
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-20
Award End Date (Contract End Date): 2024-08-31
Small Business Information
753 FOX CHASE RD SW
Rochester, MN 55902-8749
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 DAVID KALLMES
 (507) 284-4715
 kallmes.david@mayo.edu
Business Contact
 KEVIN KALLMES
Phone: (507) 271-7051
Email: kall0156@umn.edu
Research Institution
 MAYO CLINIC ROCHESTER
 
200 1ST ST SW
ROCHESTER, MN 55905-0001
United States

 Domestic Nonprofit Research Organization
Abstract

PROJECT SUMMARY/ABSTRACT
The long-term goal of this proposal is to improve the care of patients suffering from Large Vessel Occlusion
Acute Ischemic stroke. Currently, mechanical thrombectomy techniques can achieve revascularization in over
70% of cases, and physicians are rapidly adoption aspiration thrombectomy over stent-trievers. Aspiration
maintains equivalent angiographic and clinical outcomes to stent-retrieval, but larger catheters and new
combinatorial techniques have given rise to promises of faster, cheaper, more effective “Super Bore” devices.
The way to improve aspiration technologies is to expand the inner diameter (ID) of distal access catheters
(DACs): in vitro studies have shown that catheters with ID of 0.088” have near-perfect rates of clot ingestion in
a single pass, spurring development of multiple Super Bore 088 DAC systems. While the enthusiasm for the
088DACs remains extremely high among the interventional stroke community, limitations in recent clinical
reports point to key aspects that could readily be improved with novel design features. First, a “one-size- fits-
all” approach may not be ideal for many patients, especially women with smaller intracranial arteries.
Specifically, the middle cerebral artery (MCA), where most clots reside, has variable width. Second, the
promise of “localized flow arrest” with the large bore catheters, where the catheter itself is large enough to stop
forward flow, falls apart if the clot is not ingested immediately and “corked” clots as the tip must be pulled into
the guiding catheter, risking downstream emboli. Third, the 0.088” ID is still too small for clots that lodge in the
internal carotid artery. Finally, most of the currently proposed 088DACs are incompatible with 8Fr access
sheaths, and thus cannot be used on-label with arterial closure devices, increasing the risk of hemorrhage.
In response to these challenges, we have designed a novel, two-component, telescoping “Dual DAC” system
that, as a unit, has the same ID of other “Super Bore” DACs while achieving 8Fr short sheath compatibility.
The inner DAC provides the target 0.088” ID, yet fits into the outer DAC’s 0.101”ID. By thinning the walls of the
two nested DACs, we provide all of the performance features, and much more, of the other Super Bore 088
DACs. Our system can be placed in the MCA, but instead of a single, thick-walled 0.088” catheter, our system
allows placement of both DACs simultaneously in most patients. The inner DAC is used for aspiration, while
the outer DAC remains in the MCA for persistent local flow arrest during retrieval of the inner DAC. Further,
our inner DAC, with an OD almost 1Fr smaller than other Super Bore 088 DACs, will fit even into narrow MCAs
in smaller women. To date, we have constructed prototypes and demonstrated outstanding trackability of the
Dual DAC system in leading neurovascular simulators. In this Phase 1 STTR we propose to refine and test the
system to achieve design freeze. If successful, this research program will provide the next generation system
for clot ingestion, which we will drive forward to commercialization through GLP animal and other testing
required to achieve regulatory clearance in our Phase II.

* Information listed above is at the time of submission. *

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