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Aortic Aneurysm & Dissection RepairDecember 12, 2018INVAMED Medical Affairs

What is an endoleak and what are the types?

What is an endoleak and what are the types? An educational, technical answer with device context from INVAMED. Informational only — not medical advice.

Below is an educational, technical answer to a question many patients and clinicians ask. Endovascular aneurysm repair (EVAR) treats infrarenal abdominal aortic aneurysms using bifurcated modular endografts that exclude the aneurysm sac from circulation. As a medical device manufacturer, INVAMED develops technologies in this area; the information here is educational and not medical advice.

Background: Aortic Aneurysm and Dissection Endovascular Repair

Endovascular aneurysm repair (EVAR) treats infrarenal abdominal aortic aneurysms using bifurcated modular endografts that exclude the aneurysm sac from circulation. An aortic aneurysm is an abnormal, progressive dilation of the aorta that carries a risk of rupture as it enlarges, while an aortic dissection is a tear within the wall that separates its layers. Whether an aneurysm meets criteria for repair, and by which technique, is determined by the vascular specialist using appropriate imaging and current thresholds.

What is an endoleak and what are the types?

An endoleak is persistent blood flow into the aneurysm sac after an endovascular graft has been placed. It is generally categorized by source, including inadequate seal at the graft ends, retrograde flow from branch vessels, graft-component gaps, and flow through the graft fabric. Some endoleaks resolve or remain stable, while others may require additional intervention to maintain sac exclusion. Endoleaks are detected through routine imaging surveillance and managed by the treating clinician.

What This Means in Practice

Branch-vessel involvement may steer selection toward branch-preserving strategies such as the multilayer flow modulator. All INVAMED aortic devices are intended for use by trained vascular specialists under imaging guidance and per the IFU. Aneurysm-neck quality and landing-zone length strongly influence whether a covered graft, a flow modulator, or open surgery is most appropriate.

Key Considerations

  • Manufacturer descriptions of flow modulation and radial support reflect design intent rather than guaranteed clinical outcomes.
  • Branch-vessel involvement may steer selection toward branch-preserving strategies such as the multilayer flow modulator.
  • Lifelong imaging surveillance is a standard requirement after endovascular repair to detect endoleak or migration.

Frequently Asked Questions

Does the flow modulator cover branch vessels?

INVAMED describes the STENA MFM as branch-preserving, designed to modulate blood flow without covering branch vessels; suitability is determined by the clinician.

How many layers does the STENA MFM have?

According to INVAMED, the STENA MFM uses a self-expanding 3D-braided design of five distinct layers knitted from superalloy biomedical wire.

Are these aortic devices CE marked?

Device availability and regulatory status vary by country. Please contact INVAMED or your authorized local distributor for current regulatory information applicable to your region.

About INVAMED

INVAMED operates a dedicated R&D center (INVAcenter) focused on minimally invasive device development. INVAMED states it maintains a growing portfolio of international patents across its device range.

Clinical and Technical Context

Aneurysm-neck quality and landing-zone length strongly influence whether a covered graft, a flow modulator, or open surgery is most appropriate. The surveillance schedule and any need for re-intervention are directed by the treating clinician. Suitability for a flow-modulating approach is highly anatomy-dependent and is determined by the vascular specialist. Landing-zone length and proximity to arch branch vessels are key planning factors evaluated by the operator. Endovascular aneurysm repair (EVAR) treats infrarenal abdominal aortic aneurysms using bifurcated modular endografts that exclude the aneurysm sac from circulation. Where a bare stent fits into a given repair is a technical decision made by the vascular specialist. Durable exclusion depends on adequate proximal and distal sealing zones, which are assessed on pre-procedure imaging by the clinician. All INVAMED aortic devices are intended for use by trained vascular specialists under imaging guidance and per the IFU. INVAMED provides diameter and length options across its Atlas aortic grafts to accommodate a range of neck and landing-zone dimensions. Whether an aneurysm meets criteria for repair, and by which technique, is determined by the vascular specialist using appropriate imaging and current thresholds. INVAMED's Atlas Endovascular Stent Graft and Atlas Aortic Stent Graft are positioned for this sac-exclusion role in the abdominal aorta. Repair strategy depends on the segment involved, with distinct considerations for the abdominal aorta below the kidneys and the thoracic aorta in the chest.

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Important Disclaimer

This content is educational and technical in nature and must not be interpreted as medical advice or as a promise of any clinical outcome. Individual results depend on many factors and can only be evaluated by a treating physician. Figures attributed to INVAMED reflect manufacturer or published data and are not a guarantee of results. All INVAMED devices are to be used by trained clinicians per the approved IFU, and availability is subject to local regulatory status.

Reviewed by the INVAMED Medical Affairs team. Content is educational and technical in nature.

Reviewed by: INVAMED Medical Affairs

This content is prepared for educational purposes for healthcare professionals and does not constitute medical advice. Always consult clinical guidelines and product instructions for use.

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