CVTVT · Project

Non-Surgical Device That Fixes Leaking Heart Valves Through a Vein

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Imagine a heart valve that's supposed to close tightly but has become leaky — blood sloshes backwards, leaving patients exhausted and eventually facing death. The only fix right now is cracking open the chest for open-heart surgery, which is so risky that fewer than 1 in 100 patients actually get it. CroíValve built a tiny device that slides in through a vein in the leg, travels to the heart, and props the valve back into working order — no surgery, no chest incision. Think of it like fixing a broken door hinge from the inside without taking the door off.

By the numbers

550,000

Patients presenting with tricuspid valve disease annually in US and EU

<1%

Patients currently receiving treatment due to surgical risks

€2.5Bn/year

Estimated market potential

€2,494,970

EU funding received

100%

Industry ratio in consortium (1 SME)

The business problem

What needed solving

Over 550,000 patients in the US and EU are diagnosed with tricuspid valve disease every year, but fewer than 1% receive treatment because the only option — open-heart surgery — is too risky for most. This leaves a massive unmet medical need and billions in potential market value untapped. Hospitals and cardiologists need a safe, non-surgical treatment they can offer to the 99% of patients currently sent home with no solution.

The solution

What was built

CroíValve developed a catheter-delivered device that restores tricuspid valve function without open-heart surgery — it enters through a vein and repairs the valve from inside the heart. The project funded clinical trials, congress presentations of clinical data at London Valves, TCT, and TVT conferences, and expansion of manufacturing capabilities toward CE Mark approval.

Audience

Who needs this

Cardiovascular medical device distributors looking for next-generation structural heart productsInterventional cardiology departments at hospitals seeking to expand cath lab proceduresLarge MedTech companies (e.g. Edwards Lifesciences, Medtronic) scouting tricuspid valve acquisitionsPrivate equity and venture capital firms investing in structural heart technologiesHealth system administrators looking to reduce heart failure readmission costs

Business applications

Who can put this to work

Medical Device Distribution

mid-size

Target: Cardiovascular device distributors and importers

If you are a medical device distributor specializing in cardiovascular products — this project developed a catheter-delivered tricuspid valve repair device targeting a market of 550,000 patients per year in the US and EU. With less than 1% of patients currently receiving treatment due to surgical risks, this device opens access to a massively underserved patient population estimated at over €2.5Bn/year.

Hospital & Cardiac Centers

enterprise

Target: Interventional cardiology departments and cardiac catheterization labs

If you run a cardiac catheterization lab looking to expand your procedure portfolio — this device enables non-surgical tricuspid valve repair delivered through a vein, requiring no open-heart surgery. It targets the 550,000 patients per year currently left untreated because surgery is too risky, potentially reducing repeat hospitalizations and generating new revenue for your cath lab.

MedTech Investment & Licensing

enterprise

Target: MedTech companies seeking portfolio expansion in structural heart

If you are a structural heart company seeking acquisition or licensing targets — CroíValve developed a transcatheter tricuspid valve device backed by EUR 2,494,970 in EU funding and clinical trial data presented at major conferences (London Valves, TCT, TVT). The addressable market exceeds €2.5Bn/year with virtually no competition from existing surgical approaches.

Frequently asked

Quick answers

What is the estimated market size and pricing potential?

The project data cites a market potential exceeding €2.5Bn per year based on 550,000 patients presenting annually in the US and EU. Specific device pricing is not disclosed in the project data, but transcatheter heart valve devices typically command premium pricing given the alternative is open-heart surgery.

Can this device scale to high-volume manufacturing?

The project objective explicitly states that funding was used to expand manufacturing capabilities. As an SME Instrument Phase 2 project (EUR 2,494,970), the focus was on moving from prototype to commercial-scale production alongside clinical validation.

What is the IP and licensing situation?

CroíValve's management team has a stated track record in patenting and commercializing medical devices. The device was invented by a leading cardiologist and refined by biomedical engineers. Specific patent details are not listed in the project data, but IP protection is standard for devices at this stage.

What regulatory approvals has it achieved?

The project aimed to complete clinical trials and demonstrate safety and efficacy for CE Mark approval. Clinical data was presented at major international conferences including London Valves, TCT, and TVT. Based on available project data, the final CE Mark status after project closure is not confirmed.

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

The project ran from 2019 to 2022 and focused on completing clinical trials for regulatory approval. The device is designed to be delivered through standard catheterization lab equipment, which means hospitals with existing cath labs would need minimal new infrastructure to adopt it.

Does it integrate with existing hospital equipment and workflows?

The device is delivered through a vein into the right heart using catheter-based techniques familiar to interventional cardiologists. This means it fits into existing catheterization lab workflows without requiring new surgical suites or specialized open-heart surgery teams.

What clinical evidence supports this device?

The project delivered congress presentations with clinical data at London Valves, TCT, and TVT — the three most prominent global conferences for transcatheter valve therapies. These venues attract the leading interventional cardiologists worldwide, indicating serious clinical validation efforts.

Consortium

Who built it

This is a single-company project — CroíValve Limited, an Irish SME, is the sole partner. That's typical for EIC SME Instrument Phase 2 grants, which fund individual companies rather than research consortia. The 100% industry composition and SME status signal that this is a commercially driven venture, not an academic exercise. With EUR 2,494,970 in EU funding and a stated plan to combine it with private investment, the company was positioned to push through clinical trials and early commercialization. The absence of university or research partners suggests the core science was already done and the focus was purely on clinical validation and market entry.

CROIVALVE LIMITEDCoordinator · IE

How to reach the team

CroíValve Limited is based in Ireland. Contact their business development team through croivalve.com for licensing, distribution, or partnership inquiries.

Order a report on this consortium See CROIVALVE LIMITED profile →

Next steps

Talk to the team behind this work.

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