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 could bring the best of both to the table.
“We’ve seen 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 secured using a novel anchor system. 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 kind of in the background preparing for this for a period and having those discussions at the leading 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.
The two met in 2016 and with funding for early-stage proof-of-concept work, they began working on what eventually became CroíValve and the Duo device.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] kind of have some limitations.”
With the already fragile makeup of the tricuspid valve, the situation is made more difficult by the growth of the valve as a result of the disease. It grows to about twice its original size, O’Keeffe said, presenting a challenge with sizes.
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 there with the native valves,” O’Keeffe said. “But what we implant still has a valve within it. … We implant a valve and have these sort of 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.
Using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the company measured a 15-point improvement in their TR symptoms.
“We see that as a really meaningful clinical improvement and the patients have gotten to that level of clinical improvement,” O’Keeffe said. “That, truthfully, surpasses the other technologies. That’s one of the pieces that, for us, is really encouraging — that we consistently see all 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 native anatomy and have a procedure that the physician can do right the first time,” O’Keeffe said. “That’s the core of the data points that have 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.
“There are other technologies that are now commercially available in the U.S. and have large clinical programs,” she said. “We’re looking to make sure that we kind of have sufficient clinical data to kind of provide people the same confidence in the technology. That’s the real focus.”