AuriGen · Project

One-Shot Heart Implant That Treats Irregular Heartbeat and Prevents Stroke Together

healthTestedTRL 6

Imagine your heart has a small pouch (the Left Atrial Appendage) that starts misfiring electrical signals, causing an irregular heartbeat — and blood clots can form there, risking a stroke. Right now, doctors can zap the misfiring tissue, but for persistent cases it only works 30% of the time. And if they also want to seal off that pouch to prevent clots, the surgery doubles to 7 hours, making it impractical. AuriGen built a tiny implant that does both jobs at once — stops the bad signals AND seals the pouch — in a single procedure with no extra surgery time.

By the numbers

10.7 million

AF patients across Europe and the US

3.6 million

Persistent AF patients in Europe and US

30%

Current treatment success rate for persistent AF

72%

PAF patients requiring at least one redo procedure

€13.5 billion

Wasted healthcare costs from redo procedures

7 hours

Procedure time when combining ablation and LAA occlusion today

$5 billion/year

EU and US persistent AF market opportunity

The business problem

What needed solving

Persistent atrial fibrillation affects 3.6 million people in Europe and the US, and current catheter ablation treatment fails 70% of the time. When doctors try to also prevent the stroke risk by sealing off the Left Atrial Appendage, the procedure doubles to 7 hours — making it impractical for hospitals and dangerous for patients. This results in €13.5 billion in wasted healthcare costs from repeated procedures.

The solution

What was built

AuriGen developed a minimally invasive cardiac implant that permanently isolates the Left Atrial Appendage both electrically (stopping arrhythmia signals) and mechanically (preventing blood clots) in a single catheter procedure with no added surgery time. Project deliverables included pre-clinical and first-in-human study work, plus marketing materials including website, brochures, and press releases for commercial launch preparation.

Audience

Who needs this

Cardiac medical device distributors in Europe and the USHospital cardiology departments and cath lab directorsHealth insurers and national health services paying for AF treatmentsElectrophysiology device companies looking for acquisition targets or partnershipsClinical trial organizations specializing in cardiac interventional devices

Business applications

Who can put this to work

Medical device distribution

mid-size

Target: Medical device distributors specializing in cardiac interventional products

If you are a medical device distributor covering European or US markets and looking for high-value cardiology products — this project developed a cardiac implant that treats persistent atrial fibrillation and stroke risk in one procedure. With 3.6 million persistent AF patients in Europe and the US and a $5 billion per year market, this is a product with massive addressable demand and no direct competitor offering the same one-shot solution.

Hospital cardiology departments

enterprise

Target: Large hospitals and cardiac catheterization labs

If you run a cardiac catheterization lab dealing with repeated AF ablation procedures — this implant could cut your redo rates dramatically. Currently 72% of persistent AF patients need at least one repeat procedure, costing your facility time and resources. A one-shot device that electrically and mechanically isolates the LAA could free up cath lab capacity and reduce per-patient costs.

Health insurance and payers

enterprise

Target: Health insurance companies and national health services

If you are a health insurer or payer dealing with the burden of repeated atrial fibrillation procedures — this technology addresses a problem that currently wastes €13.5 billion in healthcare costs across Europe and the US. By combining ablation and LAA occlusion into one procedure instead of two separate ones, it could significantly reduce the number of costly redo surgeries your plans cover.

Frequently asked

Quick answers

What would a hospital pay for this implant compared to current treatment costs?

The project data does not specify a per-unit price. However, the objective highlights that current redo procedures for persistent AF cost healthcare systems €13.5 billion total, and 72% of patients need at least one repeat procedure. A device that reduces redos would justify premium pricing against that cost baseline.

Can this scale to serve the full market of 3.6 million persistent AF patients?

The project targeted CE approval for European launch in Tier 1 markets (Germany, France, Italy, UK) first, then planned to scale via specialist distributors into broader European, US, and international markets. The $5 billion per year market opportunity cited in the objective suggests significant scaling potential once regulatory clearance is achieved.

What is the IP and licensing situation?

AuriGen Medical Limited is the sole partner and coordinator — a single Irish SME with full ownership of the technology. Based on available project data, all IP would be held by AuriGen Medical. Licensing or distribution partnerships would need to be negotiated directly with the company.

What regulatory approvals does this device have?

The Phase 2 project aimed to complete pre-clinical studies, first-in-human clinical studies, and market development work required for CE approval in Europe. The project closed in June 2021. Based on available project data, the exact regulatory status post-project is not confirmed.

How long before this could be adopted in a hospital setting?

The project ran from 2018 to 2021 and targeted CE approval during that period. The device was being prepared for commercial launch in Tier 1 European markets. Based on available project data, the timeline for hospital adoption depends on final regulatory clearance and commercial agreements with distributors.

Does this require new equipment or training for cardiac surgeons?

The implant is designed as a minimally invasive catheter-delivered device, meaning it fits into existing cardiac catheterization lab workflows. The key selling point is that it adds no extra surgery time — unlike current approaches that double procedure time to 7 hours. Based on available project data, standard cath lab infrastructure should suffice.

Consortium

Who built it

This is a single-company project: AuriGen Medical Limited, an Irish SME that is both coordinator and sole partner. The 100% industry composition with no university or research institute partners signals a commercially driven venture — the science is already done and the company is focused on product development, clinical validation, and market entry. For a business partner, this means you'd be dealing directly with the product owner with full decision-making authority and no complex consortium IP negotiations.

AURIGEN MEDICAL LIMITEDCoordinator · IE

How to reach the team

AuriGen Medical Limited is based in Ireland. Contact their business development team through aurigenmedical.com for partnership and distribution inquiries.

Order a report on this consortium See AURIGEN MEDICAL LIMITED profile →

Next steps

Talk to the team behind this work.

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