Edwards’ Evoque valve became the first transcatheter therapy to receive FDA approval to treat TR in February. This month, Abbott became the second with its TriClip transcatheter edge-to-edge repair (TEER) system picking up an FDA nod. With Edwards’ device designed to replace the native valve and Abbott’s designed to repair it, CroíValve’s investigational Duo tricuspid coaptation valve system could bring the best of both to the table.
“We’re seen as sort of the best of both worlds,” CEO Lucy O’Keeffe told MassDevice in an interview.
Duo features a coaptation valve that works in tandem with the native tricuspid valve to restore valve function. Delivered using percutaneous techniques, Duo is anchored in a novel way — it is secured across the annulus by a support catheter anchored to a stent in the superior vena cava. This anchor system leaves the right heart and native valve apparatus untouched.
The system won FDA investigational device exemption at the start of the year and kicked off an early feasibility study for the Duo system. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR).
“We’re really excited to get our technology into the hands of leading physicians,” O’Keeffe said. “We’ve been in the background preparing for this trial for a period and having those discussions at the leading U.S. centers. They’re really keen to get to use our technology and see the advantages that it can provide.”
CroíValve’s mission and technology
Co-founder Dr. Martin Quinn, an interventional cardiologist, first conceived the concept now undertaken by CroíValve. Quinn performed the first transcatheter aortic valve replacement (TAVR) implant in Ireland and saw the value of that type of technology. O’Keeffe, meanwhile, was working on early TAVR programs at Medtronic, also understanding the potential impact.
O’Keeffe said the company set out to design something specifically for the challenges of the tricuspid valve, finding a suitable treatment option for TR.
Current solutions for the tricuspid valve often come in a repurposed form from original designs made for the mitral valve. However, that may not solve the entire problem.
“There are some unique challenges with the tricuspid valve,” O’Keeffe explained. “[Existing solutions] have some limitations.”
With the already fragile makeup of the tricuspid valve, the situation is made more difficult by the dilation of the right heart and valve as a result of the disease. It grows to about twice its original size, O’Keeffe said, presenting a challenge with appropriate sizing.
“Our device is designed to fit most patients as it’s not dependent on annulus sizing or leaflet gap,” O’Keeffe explained.
On top of that, the surrounding structures — some critical — are fragile, too. If disrupted, this can in turn disrupt the normal function of the heart. The CroíValve approach has these challenges in mind, potentially making a difference in a diverse patient population with a straightforward, consistent implant that doesn’t disrupt normal cardiac function.
“We still work with the functionality that’s still there with the native valves,” O’Keeffe said. “”We implant a valve within the native valve that still allows the native leaflets to function naturally in sealing around the device. So what we have is these two valves working in tandem together.”
What’s next
CroíValve already saw early clinical trial success in Europe and hopes to bring that to its FDA IDE trial in the U.S. Early data showed meaningful symptomatic improvements in diverse patients, with patients now beyond a year post-treatment.
An earlier study showed that 90% of patients experienced a 15-point or more improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) measuring patient quality of life.
“We see that as a really meaningful clinical improvement that the patients have reached that level of clinical improvement,” O’Keeffe said. “That, truthfully, surpasses the other technologies. That’s one of the data points that, for us, is really encouraging — that we consistently see most patients feeling better.”
Other measures showed improvements, too, with a six-minute walk test producing positive outcomes and highlighting potential quality of life enhancements beyond the TR symptoms.
“The really positive piece in terms of clinical data is the ability to treat the diverse range of the native anatomy and have a procedure that the physician can do right the first time,” O’Keeffe said. “That’s a core element that has been so encouraging from early clinical work.”
Expanding clinical validation to the U.S. marks the next key step on the journey for CroíValve. O’Keeffe said the company sees value in working with leading U.S. centers that “really understand this disease” along with the challenges of other technologies. This should, she said, highlight the value of the company’s own approach.
O’Keeffe said the company is keen to make sure more doctors and patients get to experience the valve as it works toward challenging the TR treatment market.
“Doctors who have used Duo give it top scores for ease of use,” she said. “They find it has virtually no learning curve and no precision imaging requirement like other technologies.”
“There are other technologies that are now commercially available in the U.S. and have large clinical programs. We’re looking to make sure we develop our clinical data to further validate the technology. That’s the real focus.”
