Three developments worth knowing
SIRONA, three years out
88.2%Freedom from clinically driven target lesion revascularization at 3 years with sirolimus-coated balloon, versus 80.2% with paclitaxel-coated balloon (HR 0.60, 95% CI 0.36–0.97, p=0.01) in 482 patients with femoropopliteal disease — presented at TCT 2026 on November 2 and published in JACC: Cardiovascular Interventions.
Caveat: the trial was powered for 12-month endpoints, so the 3-year finding is exploratory; follow-up continues to 5 years.
Hydrogel embolic, expanded indication
100%Freedom from major adverse events through 30 days in the HALT study (130 patients, 22 US sites), with 90.0% clinical success. On October 29, the FDA expanded the indication for the Instylla Embrace Hydrogel Embolic System to peripheral arterial bleeds in vessels ≤6 mm.
AI-powered IVUS, cleared
On November 4, the FDA granted 510(k) clearance to the Evident Vascular Guidance System and Evident peripheral imaging catheters for AI-powered intravascular ultrasound during peripheral vascular interventions.
Note: not available for sale in the US or other jurisdictions yet; clearance is a milestone, not a launch.