<h1>Regulator approves first sirolimus-coated balloon for coronary disease, allowing nationwide commercial sales and metal-free alternative</h1> A national health regulator granted commercial market authorization in Brazil to a medical device manufacturer's sirolimus-coated balloon for coronary artery disease, permitting nationwide sales and positioning the device as the first approved sirolimus-coated balloon in that market. The approval may shift competitive dynamics by offering a metal-free alternative to drug-eluting stents and supports the manufacturer's broader regulatory filings for related devices. The company cites an extensive clinical-trial program as the evidentiary basis; stakeholders should monitor post-market surveillance, labeling conditions, reimbursement decisions, and any ongoing regulatory commitments tied to the approval.