Ultra-Low Profile, Upper Extremity Access for AAA Repair
Enabling AAA patients with small or calcified vessels, or bilateral femoral access concerns to undergo EVAR with AxSES TM via a single upper extremity access site. AxSES makes AAA repair less invasive and available for more patients.
Overview
AAA Repair Can Be Constrained by Device Size and Delivery Path
Endovascular repair is the standard of care for abdominal aortic aneurysm, yet current EVAR systems rely on large-bore devices and bilateral femoral delivery. These constraints exclude a significant portion of patients and introduce procedural complexity, risk, and cost.
The challenge is structural:
Delivery systems are too large for many patients with small or diseased vessels
Femoral access requires two groin punctures and complex retrograde navigation
Access-related complications contribute to longer procedures and extended recovery
As a result, a significant portion of patients are excluded from EVAR or face more invasive treatment pathways.
The AxSES™ Solution
Ultra–Low Profile Engineering Enables Expanding EVAR to Patients Not Receiving EVAR Treatment Today and Upper Extremity Access
AxSES™ was purpose-built to overcome both size and delivery limitations in AAA repair.
By combining an ultra–low-profile stent graft with a delivery system engineered specifically for single-site, upper extremity access, AxSES™ enables antegrade delivery from a single puncture or incision in the shoulder area and eliminates the need for bilateral femoral access.
Key advantages:
Ultra–low-profile delivery system designed for small vessels
Enables access through smaller arteries, expanding eligibility while reducing access-related complications.
Single, small arm/shoulder artery puncture
A single arterial puncture above the diaphragm simplifies the procedure and eliminates bilateral groin access.
Antegrade delivery aligned with natural blood flow
Delivers the device in the direction of natural blood flow, improving control and procedural efficiency.
Elimination of bilateral femoral access
Enables access through smaller arteries, expanding eligibility while reducing access-related complications.
Clinical and Economic Impact
Designed to Simplify Procedures and Improve System Economics
This approach expands eligibility for patients with smaller or diseased vessels, including women and patients with challenging anatomies, while offering a less invasive option for all eligible patients.
By reducing access complexity and invasiveness, AxSES™ has the potential to materially improve both clinical workflow and hospital economics.
Potential impact includes:
Reduced access-related complications
Shorter procedure times
Faster ambulation and recovery
Simplified procedural workflow
Potential for outpatient or reduced-length-of-stay treatment
These factors are central to physician adoption, hospital efficiency, and long-term reimbursement alignment.
Market Validation
Independent Feedback from Practicing Vascular Surgeons
An anonymous survey of practicing vascular surgeons assessed market receptiveness to AxSES™, assuming successful clinical outcomes, regulatory approval, and reimbursement. Results indicate strong surgeon interest, supporting AxSES™’s potential for adoption and commercial scalability.
Team and Scientific Advisory Board
Deep Clinical, Engineering, and Commercial Expertise
Major Medical Devices is led by world-class EVAR engineers, clinicians, and operators with extensive experience bringing complex vascular technologies to market.
Supported by a Scientific Advisory Board comprised of leading vascular surgeons and interventional experts globally.
Engineering, IP, and Differentiation
Purpose-Built and Protected
AxSES™ is engineered by leaders in low-profile EVAR and vascular device development, designed specifically to overcome known limitations of femoral-based systems rather than adapting legacy platforms.
The approach is protected by broad intellectual property, including:
Granted Claim #1 in Japan covering single arterial puncture above the diaphragm for AAA repair
Multiple complementary patent families
Broad international filings across major jurisdictions
This IP position supports durable differentiation in upper extremity AAA treatment.
News
Company Updates
Recent highlights include strategic investment and continued progress toward clinical and regulatory milestones.
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