New device to treat defective heart valve

The tricuspid valve is one of four valves in the heart that opens and closes to facilitate blood flow. In patients with a condition called tricuspid valve regurgitation, the valve doesn’t close properly.

This causes the blood to leak backwards and has a significant impact on how the heart functions.

At present the treatment options for patients with this condition are poor, but this is about to change.

Early stage medical devices company, CroíValve, has developed a minimally invasive device that treats the condition quickly and cost effectively with no need for a long hospital stay – music to the ears of patients, healthcare providers and medical insurers alike.

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"Surgery is too high risk for these patients so our device is delivered using a technique similar to that used to implant a pacemaker. Once in place, our device works in tandem with the native valve to prevent backflow," explains chief executive Lucy O'Keeffe, who co-founded CroíValve with interventional cardiologist Martin Quinn (the inventor of the device), engineer Paul Heneghan and Trinity College Dublin academic Bruce Murphy.

Martin Quinn is attached to St Vincent’s University Hospital and is the holder of multiple heart valve technology patents while Bruce Murphy is associate professor, Biomechanical Engineering, at Trinity College.

O’Keeffe and Heneghan come from biomechanical engineering backgrounds and both have long years of experience in the medical devices sector with companies such as Medtronic, Nypro Healthcare and ICON.

“From treating patients with heart failure, Martin could see how novel technology could transform their lives,” O’Keeffe says. “Where previously there was no feasible treatment option or someone had to spend months recovering from the trauma of open heart surgery, they could walk out of hospital a few days after a transcatheter aortic valve implant. He saw that other valves in the heart could benefit from this type of treatment option and that a solution with a simple implantation technique would have the best chance of success and wide scale adoption.”

CroíValve is based at Trinity’s Centre for Bioengineering and was officially formed in 2016.

However, the concept has been in development for a number of years with patents filed in 2014. The company employs two people full-time and expects to spinout from the university in 2018.

Funding to date has come from private investment and a commercialisation grant in the order of €500,000 from Enterprise Ireland. CroíValve is now embarking on a multi-million funding round to take the device to the next stage.

“The device requires extensive testing and clinical evaluation to ensure it is safe and effective so it will be around 2020 when we see the first ‘in man’ implants,” O’Keeffe says.

“At the moment, we are working with key opinion leaders in the area of transcatheter valve intervention to ensure the benefits of the CroíValve solution are fully understood by the cardiology community.”

Tricuspid regurgitation (TR) affects over half a million new patients every year in the EU and US, and O’Keeffe says CroíValve’s solution will transform and extend the lives of those with the problem.

“Patients with TR endure long and repeated hospitalisations because this disease causes loss of appetite, reduced absorption of medication, impaired kidney function and increased cardiovascular issues – meaning they have no quality of life. Currently, less than 1 per cent of patients receive surgical treatment,” she says.

CroíValve does not have the market completely to itself as there are other companies looking at solutions to the problem. However, O’Keeffe says her company’s product addresses the gaps that exist in competing devices while it also has the edge as it is quicker and easier to deliver.

“It only takes a few minutes to implant while the other solutions being developed involve complex procedures that take hours. The CroíValve is also atraumatic as it doesn’t have the tissue penetrating anchors used by our competitors.”