CroíValve’s Duo takes a unique approach for treating tricuspid regurgitation

CroíValve is making inroads in the tricuspid regurgitation (TR) treatment market currently occupied by Abbott and Edwards.

In February 2024, Edwards’ Evoque tricuspid valve became the first TR treatment to win FDA approval, followed by Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system in April.

Edwards designed its device to replace the native heart valve, while Abbott designed its TEER system to repair it.

CroíValve’s investigational Duo tricuspid coaptation valve system is different, with an approach that CEO Lucy O’Keeffe calls “the best of both worlds.”

O’Keeffe, who comes from an engineering background, was working on early TAVR programs at Medtronic when she met CroíValve co-founder Dr. Martin Quinn, the cardiologist who placed the first transcatheter aortic valve replacement (TAVR) implant in Ireland.

Together, they set out to design something specifically for the tricuspid valve. The Duo system won FDA investigational device exemption at the start of the year, kicking off an early feasibility study.

“There are some unique challenges with the tricuspid valve,” O’Keeffe told Medical Design & Outsourcing. “[Existing solutions] have some limitations.”

What the technology is and does

TR occurs when the tricuspid valve’s leaflets fail to close properly, leaving a gap between the native leaflets. The CroíValve Duo is designed to fill the gap inside the valve, allowing the native leaflets to seal against the device and restoring their function.

“The leaflets actually position our device where they want it to be,” O’Keeffe said. “We’re the only device where we have the native leaflets still functioning, working with a valve functioning in the gap between the native leaflets.”

The device’s small size enables easy delivery through the vasculature, but it’s still large enough to fill the gap between the leaflets.

O’Keeffe said Duo has a unique anchoring system that holds the device across the annulus without contacting the right heart. It’s secured with a catheter arm to avoid contact with the frail section of the heart.

The Duo device is tethered to a stent that is anchored in the superior vena cava outside the heart.

“It’s a combination of working with the native valve to restore function and then maintaining normal cardiac motion and function,” O’Keeffe said. “It means we’ve seen very meaningful improvement in patient symptoms with a really straightforward procedure while avoiding some of the safety events that have been seen with other options. It’s been intended as a universal fit to accommodate the diverse patient population with tricuspid disease.”

What makes CroíValve Duo unique?

O’Keeffe says the CroíValve approach leverages familiar interventional cardiology approaches to do “quite a lot of things differently.”

The individual elements of the company’s technology — such as valves, stents and catheters —  aren’t new. But bringing the components together creates something that the rest of the market isn’t offering, O’Keeffe said.

“The various elements themselves are not unique,” she said. “It’s the combination of them and what we’re asking them to do — that’s the unique thing.”

Anchoring something across the valve without contacting the right heart and having the anchor sit in a vein outside the heart is unique, she said, as is having the system work in tandem with the native valve.

“It’s sort of a valve-in-valve model, but with unique benefits” O’Keeffe said.

Challenges for treating TR

One challenge of treating TR is managing the varying patient population and the different sizes of the tricuspid valve.

“That’s been a journey for us, to understand the level of variability,” O’Keeffe said. “When we started, we thought we understood the variability. The more patient data we get, the more variable we understand that to be. That’s a key piece.”

With the Duo system, CroíValve has found what O’Keeffe called a “one-size-fits-all” solution that’s accessible for any physician to use.

O’Keeffe said the company had to make sure that its solution wasn’t just accessible and suitable for patients, but also for physicians to conduct these procedures on a consistent basis. With other approaches, procedures may require precision imaging and a certain level of proficiency. With Duo, the company utilized familiar technologies and techniques to ensure ease of use and good clinical outcomes from the very first case.

“Maybe this comes from the origins of having the device designed by a physician in that we don’t need that precision imaging,” O’Keeffe said. “There isn’t really a learning curve to do our procedure.”

Early physician feedback brought back high scores in terms of ease of use, according to O’Keeffe, signaling Duo’s potential for broad adoption.

“All these devices start with these specialist centers,” O’Keeffe said. “But, we’re mindful. We want it to be easy to adopt so that it can be easily incorporated into standard of care practice.”

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