Question · Q3 2025
Chris Pasquale from Nephron Research inquired about the AGENT drug-coated balloon's launch success and its potential to become a billion-dollar product. He asked about the sustainability of growth in the interim period before STANCE trial readout, particularly within the in-stent restenosis (ISR) indication and in anticipation of new competition, and whether physicians are already using the product off-label for de novo lesions.
Answer
Chief Medical Officer Dr. Ken Stein confirmed ample room for continued AGENT growth even before the STANCE trial readout, citing the new TPT and improved reimbursement. He highlighted the opportunity to at least double the indicated population by expanding beyond ISR into small vessel bifurcation disease and other de novo lesions. Dr. Stein mentioned upcoming AGENT post-approval study data at TCT, which will provide insights into real-world usage and outcomes. He expressed confidence in AGENT's position, noting fundamental advantages of paclitaxel in drug-coated balloons, and reiterated its role as a long-term growth driver.