Devices

FDA Panel to Discuss Abbott’s TriClip Data

FDA is convening a 2/13 advisory committee meeting to discuss the clinical significance of Abbott Medical’s TRILUMINATE pivotal trial that evaluated the company’s TriClip G4 System (TriClip) for improving health status in patients with symptomatic, severe tricuspid regurgitation (TR), whose symptoms and TR severity persist despite optimal medical therapy.

The primary endpoint of the randomized cohort was a hierarchical composite of all-cause mortality or tricuspid valve surgery, number of heart failure (HF) hospitalizations, and health status improvement by greater than or equal to 15 points measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, which is assessed at 12-months follow-up.

An FDA briefing document says the primary endpoint analysis showed “superiority of the TriClip group vs. the control group for the hierarchical composite endpoint of death or tricuspid valve surgery, number of HF hospitalizations, and a 15-point KCCQ improvement tested using the Finkelstein-Schoenfeld method, and the win-ratio point estimate was 1.44 in favor of the TriClip group.” The panel will be asked to discuss the clinical significance of these results, the agency says.

The briefing document also noted that the primary endpoint was met in the intent-to-treat and “as treated” population, but was not met in “per protocol” population. “In addition, Covid-19 related deaths and HF hospitalizations as well as subsequent primaiy endpoint events, if any, were excluded from the primary analysis,” it says. “When these events were included in the primary analysis, the primary endpoint was not met. The panel will be asked to discuss the robustness of the superiority of the TriClip to control.”

Additionally, the agency says the pivotal trial was unblinded (open-label) and that the patient-reported outcomes such as the KCCQ score could be subject to the placebo effect in an unblinded trial. “The primary endpoint of the TRILUMINATE pivotal trial was met, driven only by KCCQ score improvement in the device group; mortality or tricuspid valve surgery rates were similar between treatment groups, and the HF hospitalization rate was numerically higher in the TriClip group vs. the control group,” it says. “The panel will be asked to discuss the strengths and limitations of the primary endpoint results considering potential placebo effects and the lack of reduced mortality or HF hospitalization rates through 12 months in the TriClip group vs. the control group.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome