Dive Brief:
- An advisory committee to the Food and Drug Administration overwhelmingly backed Abbott’s Triclip tricuspid valve device, teeing up a potential market authorization.
- The agency’s Circulatory System Devices panel on Tuesday voted unanimously in favor of the safety of the device. The panel also voted 12-2 in favor of Triclip’s efficacy and 13-1 that the device’s benefits outweigh the risks.
- Advisory panels do not have the power to approve devices. The decision now goes to the FDA, which will consider the committee’s votes and discussion. Abbott expects a decision in 2024. Meanwhile, William Blair analysts expect approval within 90 days, they wrote in a Wednesday note.
Dive Insight:
Abbott’s Triclip device is part of a push from cardiac companies to develop valves to treat tricuspid regurgitation, when the heart’s tricuspid valve leaflets do not close properly, causing blood to leak backward into the right atrium. The disease can cause patients’ hearts to pump harder to move blood through the valve.
Edwards Lifesciences recently received FDA approval for its transcatheter tricuspid valve replacement device, Evoque, notably without an advisory panel meeting. The company hopes Evoque follows in the footsteps of its landmark transcatheter aortic valve replacement devices and procedures to treat aortic stenosis.
While Edwards’ Evoque device is for tricuspid transcatheter valve replacement, Abbott’s Triclip is indicated for transcatheter valve repair. However, analysts believe both devices can successfully exist in the market.
The tricuspid valve is often referred to as the “forgotten valve” as other treatments for aortic and mitral valves have been brought to market, leaving few options for patients with tricuspid regurgitation beyond taking medications to manage their health or open-heart surgery, a theme that came up throughout the meeting.
“If we can present an option that's low risk and minimally invasive, that's a game changer for all the patients out there that can benefit from this,” said Jennifer Schwartzott, the patient representative on the panel, who is a non-voting member. “Heart failure is not fun. I have been there — it is not fun at all. I'm lucky that the medications work on me. But if they were to stop working on me or my disease were to progress, I would want to have something like this on the market and available, and the patients deserve that.”
Potential placebo effect
One point debated by panelists was whether patient responses for quality of life were impacted by the study being open-label. Patients reported their quality of life at 12 months after surgery using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a self-administered measure of patients’ health status. Abbott used the change in KCCQ scores at 12 months as a component of the primary endpoint.
The FDA specifically requested panelists to discuss if a placebo effect from the trial being unblinded had a meaningful impact on KCCQ scores.
Some panelists argued that there could be a placebo effect with patients knowing the treatment they received. However, several agreed that while there is some placebo effect happening, Abbott adequately accounted for interference and the fact that the results held up one year after the procedure reduced the placebo influence.
“I feel like they did a good job, and I feel comfortable that you can't attribute all of the benefit merely to placebo,” said Bradley Bart, staff physician and co-director of the heart failure program at the Minneapolis VA Medical Center. “I think the data line up pretty well.”
David Friedman, cardiologist and director of the heart failure program at West Carver Medical Group, agreed there were offsets to the placebo effect but still argued that further study was needed.
“One year of time — this study is not enough. We need a lot more time,” Friedman said. “And we need a bigger demographic sample size. We need different types of patients, not just caucasians. We need a lot of different ethnicities represented too going forward.”
Committee members also stressed the need for longer study times, a robust training program for doctors and heart teams, and potential complications for future care like other heart procedures after implanting Triclip.
Despite these questions and concerns, panelists voiced overall support for the device when explaining the reasoning for their votes.
