No new concerns on Abbott's heart device ahead of expert panel meeting: FDA

Abbott heart device: The US Food and Drug Administration (FDA) staff reviewers offered a reassuring assessment on Friday regarding the safety and effectiveness of Abbott's heart valve repair device, designed for patients at risk for surgery. The evaluation precedes the FDA's upcoming independent expert panel meeting scheduled for Tuesday, during which recommendations will be made on the clearance of the device, known as TriClip, for patients with tricuspid regurgitation (TR).

Tricuspid regurgitation (TR) is a condition where the tricuspid valve, responsible for separating the right lower heart chamber from the right upper heart chamber, fails to close tightly, potentially leading to heart failure. According to government data, an estimated 1.6 million Americans are affected by this disorder.

While the FDA review did not raise new safety concerns, it did highlight a notable absence of evidence indicating reduced mortality or hospitalisations among patients who received the TriClip implant compared to those on medical therapy alone.

JP Morgan analyst Robbie Marcus commented in a note that despite the lack of a mortality or hospitalisation benefit, the limited alternatives available should drive approval and adoption of the TriClip device. He noted that the overall tone and substance of the briefing documents were supportive of this view.

The TriClip device, already approved in over 50 countries, is inserted through the femoral vein in the leg and is then guided and clipped onto the tricuspid valve. Earlier this month, the FDA approved a similar device from Abbott's rival, Edwards Lifesciences, for the treatment of patients with TR.

(With Reuters inputs.)