# New Arterial Sheath for Stroke and Other Neurovascular Interventions.

> **NIH NIH R44** · RAM MEDICAL INNOVATIONS, INC. · 2022 · $602,534

## Abstract

Project Summary/Abstract
Stroke, including ischemic stroke, is the 2nd leading cause of death in the world and 5th leading cause of death
in the United States. Recent breakthrough advances in device technology have resulted in endovascular stroke
treatment becoming the standard of care. However, stroke thrombectomy (intervention) is time sensitive with a
window to intervene in less than 16 hours following symptom onset. Patients rarely arrive to the care facility
immediately following the onset of symptoms. It is well-known that complications directly increase in proportion
to procedure time, specifically 1) a 7.7% decreased probability of functional independence for every hour of
stroke onset to successful reperfusion (“time is brain” concept), and 2) sometimes death. In addition, these time
sensitive procedures are limited due to tortuous anatomy, prevalent in the elderly (in up to 35%). This in turn
also results in higher complication rates and lessens the chance of procedural success. Specifically,
neurointerventionalists struggle with difficult anatomy and often are unable to perform these potentially life-saving
procedures in 28.9% of patients. Not only is there a delay in reaching the target intracranial artery, but radiation
exposure and contrast dose can also rise, placing the patient at additional risk. Therefore, there is a tremendous
need for a device to decrease the failure rate and improve the speed of this procedure in difficult tortuous aortic
anatomy. RAM Medical Innovations (RAM) has developed a novel carotid sheath that can quickly and safely
navigate as well as maintain stable position in this hostile anatomy. RAM's feasibility work showed significantly
faster carotid sheath insertion success rate, less endothelial injury, and reduced radiation exposure with our
nonlubricious prototype against predicate devices, all of which have an advantageous hydrophilic coating. In this
Direct to Phase 2 grant RAM plans to make and test the finalized, lubricious sheath device to demonstrate the
product's safety and time efficiency profile. Notably, RAM's device, using a lubricious component found in other
FDA approved devices seeks to reduce the potential risk of particle shedding seen with current predicates. In
preparation for FDA 510(k) application, Class II device, RAM proposes biocompatibility testing in compliance
with the FDA guidelines and ISO protocols. This would include cytotoxicity, sensitization, irritation, systemic
toxicity (acute) and hemocompatibility, using in vitro and animal models to establish measurements within
acceptable ranges. RAM also plans to perform device sterilization, design verification, packaging and
accelerated aging tests that will ensure that the product will perform reliably one-year and two-years post
sterilization. Packaging and sterilization testing will also be completed to conform to FDA and ISO standards.
Additionally, after each testing process, the device will be functionally tested to ensure t...

## Key facts

- **NIH application ID:** 10469476
- **Project number:** 5R44HL154876-02
- **Recipient organization:** RAM MEDICAL INNOVATIONS, INC.
- **Principal Investigator:** Mubin Syed
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $602,534
- **Award type:** 5
- **Project period:** 2021-08-15 → 2025-08-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10469476

## Citation

> US National Institutes of Health, RePORTER application 10469476, New Arterial Sheath for Stroke and Other Neurovascular Interventions. (5R44HL154876-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10469476. Licensed CC0.

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